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TAKHZYRO (lanadelumab-flyo) is indicated for prophylaxis to prevent attacks of hereditary angioedema (HAE) in patients ≥2 years of age.

TAKHZYRO (lanadelumab-flyo) is indicated for prophylaxis to prevent attacks of hereditary angioedema (HAE) in patients ≥2 years of age.

REIMAGINE EFFECTIVE PREVENTION

HELP study

Adult and Adolescent (≥12)

HELP OLE Study

Adult and Adolescent (≥12)

Spring Study

Pediatric (2 to <12)

One of the largest prevention studies in HAE with the longest active treatment duration1-5

TAKHZYRO is clinically proven to help prevent HAE attacks with every-2-weeks dosing that takes ≤1 minute to administer—patients experienced long-term freedom from attacks for an average of 14.8 (SD=12.4) months1,2*†‡

*In clinical studies, the majority of patients self-administered TAKHZYRO within 10 to 60 seconds.1 †Evaluated in a 6.5 month study and a 2.5-year open-label extension (OLE) study.1,2 ‡Mean duration of the attack-free period in the OLE study was 14.8 (SD=12.4) months (N=209).2 SD=standard deviation.

TAKHZYRO was studied in a range of patients with HAE type I or II

125
Patients1
  • 70% Female6
  • 30% Male6
  • 12 to 73 Years of Age7
6.5
Months
of active treatment
  • (26 weeks)1,6*
56%
previously treated
with long-term
preventive therapy1
  • 48% were on C1-INH alone6
  • 3.2% were on oral therapy6†
  • 4.8% were on both6
52%
HAD ≥3 ATTACKS/‌MONTH DURING RUN-IN PERIOD1

*One month was defined as 28 days in the pivotal trial.6 †Androgens or antifibrinolytics.6

Help Study Design

Group 2 SCREENING RUN-IN TAKHZYRO 300 MG EVERY 2 WEEKS (n=27)6 TAKHZYRO 300 MG EVERY 4 WEEKS (n=29)6 TAKHZYRO 150 MG EVERY 4 WEEKS (n=28)6 PLACEBO (n=41)6 8-WEEK FOLLOW-UP PERIOD6 2.5-YEAR OPEN-LABEL EXTENSION STUDY1 or ≥2 weeks for long-term preventive therapy washout6* 4 weeks; patients required to have ≥1 attack prior to randomization1,6† 26 weeks (6.5 months) of multicenter, randomized, double-blind treatment of patients with HAE type I or II (≥12 years of age)1,6‡§

*Long-term preventive therapy washout was only for patients ≥18 years of age.7

†Run-in period could be shortened if the patient experienced ≥3 HAE attacks before completion of the 4 weeks, and the period could be extended to 8 weeks if the patient did not experience any attacks during the 4 weeks. During the 8 weeks, patient needed to have at least 2 attacks to proceed to enrollment and randomization

‡Treatments were administered as 2 separate 1-mL injections in the upper arm every 2 weeks to maintain the blind.6

§One month was defined as 28 days in the trial.6

The pivotal trial was a multicenter, double-blind, parallel group, placebo-controlled, dose-ranging study, which assessed the safety and efficacy of TAKHZYRO in 125 patients with HAE type I or II (≥12 years of age). Patients were randomized to receive TAKHZYRO 150 mg every 4 weeks (n=28), TAKHZYRO 300 mg every 4 weeks (n=29), TAKHZYRO 300 mg every 2 weeks (n=27), or placebo (n=41) for 26 weeks (6.5 months, where 1 month was defined as 28 days). Prior to randomization, patients ≥18 years of age were required to complete a ≥2-week long-term prophylaxis washout period. All patients then entered a 4-week run-in period to determine the baseline HAE attack rate. Patients with ≥1 investigator-confirmed HAE attack during the run-in period were eligible for study enrollment and randomization. The primary efficacy endpoint was the rate of investigator–confirmed attacks during the treatment period (time frame: from Day 0 to Day 182).

Rediscover effective HAE Attack Prevention

Primary Endpoint

Significant reduction in mean attack rate* vs placebo at 6.5 months in the HELP study1,6

87%
REDUCTION
IN ATTACKS
vs placebo (Adjusted P<0.001)1†
  • TAKHZYRO 300 mg every 4 weeks resulted in a 73% reduction in attacks vs placebo (Adjusted P<0.001)1†
  • Mean monthly attack rate at baseline (during run-in period): 3.52 for TAKHZYRO every 2 weeks (n=27); 3.71 for TAKHZYRO every 4 weeks (n=29); 4.02 for placebo (n=41)6
  • Mean monthly attack rate (during treatment): 0.26 for TAKHZYRO every 2 weeks; 0.53 for TAKHZYRO every 4 weeks; 1.97 for placebo1

All data presented are for TAKHZYRO 300 mg every 2 weeks unless otherwise indicated.
*Mean monthly attack rate: number of attacks/4 weeks.1
†Adjusted P-values for multiple testing.1

SELECT IMPORTANT SAFETY INFORMATION

Hypersensitivity reactions have been observed. In case of a severe hypersensitivity reaction, discontinue TAKHZYRO administration and institute appropriate treatment.

Secondary Endpoints

Significant reduction in moderate and severe attacks and attacks requiring acute treatment vs placebo at 6.5 months1,6

Attack reduction vs placebo (Adjusted P<0.001)1,6‡
Reduction in moderate or severe attacks
Reduction in attacks requiring acute treatment
TAKHZYRO 300 mg every 2 weeks (n=27)
83%
87%
TAKHZYRO 300 mg every 4 weeks (n=29)
73%
74%

‡Adjusted P-values for multiple testing.1

Exploratory Endpoints

Freedom from attacks in HELP study1,6

of patients taking TAKHZYRO (n=27) vs 2% of patients taking placebo (n=41) during the entire 6.5-month study 1,6 REACHED ZERO ATTACKS DAY 0 MONTH 0 DOSE 1 DAY 70 MONTH 2.5 DOSE 6 DAY 182 MONTH 6.5 of patients taking TAKHZYRO (n=26) REACHED ZERO ATTACKS vs 3% of patients taking placebo (n=37) from Day 70 to Day 182 of the study 6
Exploratory Endpoints DAY 0 MONTH 0 DOSE 1 DAY 70 MONTH 2.5 DOSE 6 DAY 182 MONTH 6.5 Prespecified exploratory endpoint of patients taking TAKHZYRO (n=27) HAD ZERO ATTACKS TIME TO STEADY STATE Post hoc analysis of patients taking TAKHZYRO (n=26) HAD ZERO ATTACKS vs 3% of patients taking placebo (n=37) vs 2% of patients taking placebo (n=41) during the entire 6.5-month study1,6 from Day 70 to Day 182 of the study6

All data presented are for TAKHZYRO 300 mg every 2 weeks unless otherwise indicated.

I knew that I wanted to find a preventive treatment because my HAE attacks were occurring too often, so I did some research, and I found out about TAKHZYRO.
Kelly Real TAKHZYRO patient since 2018

How do patients decide TAKHZYRO is right for them?

See why patients trust TAKHZYRO to help reduce their HAE attacks.

View Transcript

DENNIS: My doctor told me about TAKHZYRO, and my wife and I did some research. At the end of the day, I trust that my medical team and what they told me. After discussing the potential risks and the possibility of fewer HAE attacks, we decided it was the right treatment to take. And it's definitely made a big difference for me. I'm glad I listened.

KELLY: Seeing the clinical data and how effective TAKHZYRO was got my attention. It told me that this is a clinically proven treatment to help prevent HAE attacks, and that gave me the confidence to start.

JACK: For me, taking TAKHZYRO once every two weeks means it's not something I need to think about often. Plus, it's subcutaneous, which means it's injected under the skin, not in the vein. That feels manageable for me.

ANDREW: The actual injection takes about a minute, and then I'm free from thinking about my next dose for a few weeks.

SORAYA: I can inject myself, and it takes about a minute. It's an important thing I can do for myself to help reduce the frequency and severity of my HAE attacks.

NARRATOR: TAKHZYRO (lanadelumab) is a prescription medicine used to prevent attacks of hereditary angioedema, HAE, in people 2 years of age and older. It is not known if TAKHZYRO is safe and effective in children under 2 years of age. TAKHZYRO may cause serious side effects, including allergic reactions. Call your healthcare provider or get emergency help right away if you have any of the following symptoms: wheezing, difficulty breathing, chest tightness, fast heartbeat, faintness, rash, and/or hives.

NARRATOR: The most common side effects seen with TAKHZYRO were injection site reactions (pain, redness, and bruising), upper respiratory infection, headache, rash, dizziness, diarrhea, and muscle aches. These are not all the possible side effects of TAKHZYRO. For more information, ask your healthcare provider or pharmacist. You may report side effects to FDA at 1-800-FDA-1088. TAKHZYRO has not been studied in pregnant or breastfeeding women. Talk to your healthcare provider about the risk of taking TAKHZYRO if you are pregnant, plan to be pregnant, are breastfeeding, or plan to breastfeed.

NARRATOR: Talk to your healthcare provider about TAKHZYRO, the only preventive HAE treatment you take as a subcutaneous injection just once every two weeks.

About 97% of patients in the HELP study enrolled in the 2.5-year extension study1,2

TAKHZYRO is clinically proven to help prevent HAE attacks with every-2-weeks dosing that takes ≤1 minute to administer—patients experienced long-term freedom from attacks for an average of 14.8 (SD=12.4) months1,2*†‡

*In clinical studies, the majority of patients self-administered TAKHZYRO within 10 to 60 seconds.1 †Evaluated in a 6.5 month study and a 2.5-year open-label extension (OLE) study.1,2 ‡Mean duration of the attack-free period in the OLE study was 14.8 (SD=12.4) months (N=209).2 SD=standard deviation.

TAKHZYRO was studied in a range of patients with HAE type I or II

212
Patients2
  • 109 rollover patients, which represents about 97% of patients in the pivotal trial2
  • 103 nonrollover patients2
  • 81.6% of patients completed the study or enrolled in commercial product2

*Androgens or antifibrinolytics.6

≤2.5
Years
of active treatment2
  • Patients were given TAKHZYRO 300 mg every 2 weeks for a mean duration of 29.6 (SD=8.2) months2
59%
previously treated
with long-term
preventive therapy2
  • 50% were on C1-INH alone2
  • 6.1% were on oral therapy*
  • 3.3% were on both2
35%
HAD 1 TO ≤2 ATTACKS/
MONTH at baseline2
  • 39% HAD ≥3 ATTACKS/‌MONTH at baseline2

HELP Open-label Extension Study

SINGLE DOSE OF TAKHZYRO 300 MG Patients followed until the first HAE attack occured 2 SCREENING (4 weeks, no long-term preventive therapy washout) 8 TAKHZYRO 300 MG EVERY 2 WEEKS2 Open-label treatment of patients with HAE type I or II (≥12 years of age) for up to 132 weeks 2 Rollover Nonrollover (n=109) 1 Baseline attack rate of the HELP study (4-week run-in period) was used as the baseline. Attack rate requirement: at least 1 attack in 4 weeks. 1,2 Baseline was defined as the number of investigator-confirmed attacks reported in the last 3 months. Attack rate requirement: 1 attack in 3 months. 2 (n=103) 1

The open-label extension study evaluated the safety and efficacy of TAKHZYRO for up to 2.5 years in patients with HAE type 1 or type II (≥12 years of age). It included patients from the pivotal trial (rollover n=109) and additional patients (nonrollover n=103). In the long-term study, 212 patients received TAKHZYRO 300 mg every 2 weeks for a mean duration of 29.6 (SD=8.2) months. Most patients (81.6%) completed the study or enrolled in commercial product. For rollover patients, the HELP study baseline attack rate (4-week run-in period) was used as this baseline. For nonrollover patients, baseline was defined as the number of investigator-confirmed attacks reported in the last 3 months. Rollover patients, regardless of randomization group in the pivotal trial, received a single dose of TAKHZYRO 300 mg at study entry and were followed until the first HAE attack occurred. After the first HAE attack, all rollover patients received open-label treatment with TAKHZYRO 300 mg every 2 weeks. Nonrollover patients received open-label treatment with TAKHZYRO 300 mg starting on Day 0 and continued to receive TAKHZYRO every 2 weeks throughout the duration of the treatment period. The long-term safety of TAKHZYRO was the primary endpoint in the study.2

The long-term safety of TAKHZYRO was the primary endpoint in the open-label extension study.2

Effective HAE Prevention in the Long Term

Secondary Endpoints

Patients taking TAKHZYRO for an average of 30 months experienced HAE attack reduction vs baseline2

87%
Reduction
in Attacks
vs baseline (N=209)2
0.25
mean monthly
attack rate
(N=209; baseline: 3.05)2
0.05
median monthly
attack rate
(range: 0.0-4.7; baseline: 2.00)8
  • 84% reduction in moderate or severe attacks (N=209)2
  • 93% reduction in attacks requiring acute treatment (n=106)2

All data presented are for TAKHZYRO 300 mg every 2 weeks unless otherwise indicated.

SELECT IMPORTANT SAFETY INFORMATION

Adverse Reactions: The most commonly observed adverse reactions (≥10%) associated with TAKHZYRO were injection site reactions consisting mainly of pain, erythema, and bruising at the injection site; upper respiratory infection; headache; rash; dizziness; diarrhea; and myalgia. Less common adverse reactions observed included elevated levels of transaminases; one patient discontinued the trial for elevated transaminases.

Prespecified Exploratory Endpoints

Freedom from HAE attacks for extended periods of time when taking TAKHZYRO for an average of 30 months2

Zero Attacks for

14.8 MONTHS WAS THE MEAN DURATION OF THE ATTACK-FREE PERIOD (415 days, SD=12.4 months; N=209) 2
% 98 OF DAYS ON AVERAGE FOR AT LEAST A 6-MONTH PERIOD* FOR AT LEAST A 6-MONTH PERIOD Mean study duration: 29.6 (SD=8.2) months 2 (N=209, SD=6%) 2 8 10 out of PATIENTS (81.8%) 14.8 MONTHS ON AVERAGE Mean duration of attack-free period: 415 days (SD=12.4 months) 2
8 10 out of PATIENTS (81.8%) FOR AT LEAST A 6-MONTH PERIOD (N=209) 2
(N=209) 2 % 98 OF DAYS ON AVERAGE DURING TREATMENT PERIOD*

All data presented are for TAKHZYRO 300 mg every 2 weeks unless otherwise indicated.

*The percentage of days with zero attacks was calculated by counting the number of days in the treatment period without an HAE attack and dividing by the number of days the patient spent in the treatment period.8

Long-term, open-label extension data were consistent with the safety profile and efficacy in the pivotal trial.1,2

How do patients decide TAKHZYRO is right for them?

See why patients trust TAKHZYRO to help reduce their HAE attacks.

View Transcript

DENNIS: My doctor told me about TAKHZYRO, and my wife and I did some research. At the end of the day, I trust that my medical team and what they told me. After discussing the potential risks and the possibility of fewer HAE attacks, we decided it was the right treatment to take. And it's definitely made a big difference for me. I'm glad I listened.

KELLY: Seeing the clinical data and how effective TAKHZYRO was got my attention. It told me that this is a clinically proven treatment to help prevent HAE attacks, and that gave me the confidence to start.

JACK: For me, taking TAKHZYRO once every two weeks means it's not something I need to think about often. Plus, it's subcutaneous, which means it's injected under the skin, not in the vein. That feels manageable for me.

ANDREW: The actual injection takes about a minute, and then I'm free from thinking about my next dose for a few weeks.

SORAYA: I can inject myself, and it takes about a minute. It's an important thing I can do for myself to help reduce the frequency and severity of my HAE attacks.

NARRATOR: TAKHZYRO (lanadelumab) is a prescription medicine used to prevent attacks of hereditary angioedema, HAE, in people 2 years of age and older. It is not known if TAKHZYRO is safe and effective in children under 2 years of age. TAKHZYRO may cause serious side effects, including allergic reactions. Call your healthcare provider or get emergency help right away if you have any of the following symptoms: wheezing, difficulty breathing, chest tightness, fast heartbeat, faintness, rash, and/or hives.

NARRATOR: The most common side effects seen with TAKHZYRO were injection site reactions (pain, redness, and bruising), upper respiratory infection, headache, rash, dizziness, diarrhea, and muscle aches. These are not all the possible side effects of TAKHZYRO. For more information, ask your healthcare provider or pharmacist. You may report side effects to FDA at 1-800-FDA-1088. TAKHZYRO has not been studied in pregnant or breastfeeding women. Talk to your healthcare provider about the risk of taking TAKHZYRO if you are pregnant, plan to be pregnant, are breastfeeding, or plan to breastfeed.

NARRATOR: Talk to your healthcare provider about TAKHZYRO, the only preventive HAE treatment you take as a subcutaneous injection just once every two weeks.

Whenever I got an abdominal attack, I would be physically drained. I felt like a battery that was at 0%.
JENNY Real TAKHZYRO patient since 2018

An open-label, multicenter study in patients with HAE as young as 2 years of age1

TAKHZYRO was studied in pediatric patients 2 to <12 years of age with HAE type I or II1

21
PEDIATRIC PATIENTS1
  • 57% female9
  • 43% male9
  • 4 patients aged 2 to <6 years9
  • 17 patients aged 6 to <12 years9
52
WEEKS
of active treatment1
24%
previously treated
with long-term preventive therapy9
  • 24% had a history of laryngeal attacks9

The safety and pharmacokinetics of TAKHZYRO were the co-primary endpoints in the SPRING study.9

The SPRING Study Design

SCREENING OBSERVATION* 2 TO <6 YEARS TAKHZYRO 150 mg EVERY 4 WEEKS9† (n=4) 6 TO <12 YEARS TAKHZYRO 150 mg EVERY 2 WEEKS9 6 TO <12 YEARS TAKHZYRO 150 mg EVERY 2 WEEKS9 (n=17) FOLLOW-UP PERIOD 2 TO <6 YEARS TAKHZYRO 150 mg EVERY 4 WEEKS9 4-week screening period9 4-12 weeks (≥1 attack per 12 weeks)9 Open-label treatment period A 26 weeks9 Open-label treatment period B 26 weeks9 2 or 4 weeks9

*Eligible patients underwent a 4- to 12-week baseline observation period before initiating treatment with TAKHZYRO.9

†Patients aged 2 to <6 years received 150 mg every 4 weeks for the 52-week treatment period.9

‡Patients aged 6 to <12 years were to receive 150 mg every 2 weeks for 52 weeks and had an option to switch to every 4 weeks if they were attack free for 26 weeks.9

The primary endpoints of this phase 3, open-label, multicenter pediatric trial were to assess the safety and pharmacokinetics of TAKHZYRO in 21 children with HAE type I or II (2 to <12 years of age). Efficacy was a secondary endpoint of the study, specifically the normalized number of investigator-confirmed HAE attacks during treatment compared to the baseline HAE attack rate during the 4- to 12-week observation period. The treatment period was 52 weeks, divided into 26-week treatment periods A and B. In treatment period A, patients aged 2 to <6 years (n=4) and 6 to <12 years (n=17) received TAKHZYRO 150 mg every 4 weeks and 150 mg every 2 weeks, respectively. In treatment period B, patients in the 2 to <6 years age group continued receiving 150 mg every 4 weeks, while patients in the 6 to <12 years age group were permitted to switch to 150 mg every 4 weeks if they were well controlled during treatment period A. Seven patients aged 6 to 12 years switched to 150 mg every 4 weeks during treatment period B, and 1 patient aged 2 to <6 years switched to 150 mg every 2 weeks during treatment period B after experiencing recurrent attacks. Patients were followed up for 2 or 4 weeks, depending on their dosing schedule.1,9

Established effectiveness and safety profile in pediatric patients 2 to <12 years of age1

Co-primary Endpoint

Use of TAKHZYRO for patients 2 to <12 years of age was supported by extrapolation of efficacy data from the HELP study, with additional pharmacokinetic analyses showing similar drug exposures between adults and pediatric patients; and safety and pharmacodynamic data from the SPRING study.1

Lanadelumab-flyo exposures in pediatric patients 2 to <12 years of age receiving TAKHZYRO 150 mg every 2 weeks or every 4 weeks were comparable to those in adult patients receiving TAKHZYRO 300 mg every 2 weeks1

  • Pharmacokinetics (Co-primary Endpoint): Patients aged 2 to <12 years taking TAKHZYRO in the 52-week open-label study experienced systemic exposure to TAKHZYRO9
Secondary Endpoints

Limitations

Because this was a noncontrolled, open-label study that enrolled 21 pediatric patients and lacked statistical hypothesis testing, these data have less evidentiary value than a double-blind, placebo-controlled study. Further confirmatory studies are required to draw any conclusions from these data.

Patients aged 2 to <12 years taking TAKHZYRO in the 52-week open-label study experienced attack reduction vs baseline1,9

  • 95% reduction in attacks on average vs baseline (N=21)9*
    • Mean monthly attack rate at baseline (during observation period): 1.84 (N=21)9
    • Mean monthly attack rate on treatment: 0.08 (N=21)9
  • 76% of patients experienced freedom from attacks for the entire 52-week study (n=16)9
  • 99.5% of days on average with zero attacks during the entire treatment period (n=21)9

All data presented are for the total population of pediatric patients taking TAKHZYRO 150 mg every 2 or every 4 weeks.
*Baseline was defined as the frequency of HAE attacks in pediatric patients before they started TAKHZYRO6

SELECT IMPORTANT SAFETY INFORMATION

Use in Specific Populations: The safety and efficacy of TAKHZYRO in pediatric patients <2 years of age have not been established.

How do patients decide TAKHZYRO is right for them?

See why patients trust TAKHZYRO to help reduce their HAE attacks.

View Transcript

DENNIS: My doctor told me about TAKHZYRO, and my wife and I did some research. At the end of the day, I trust that my medical team and what they told me. After discussing the potential risks and the possibility of fewer HAE attacks, we decided it was the right treatment to take. And it's definitely made a big difference for me. I'm glad I listened.

KELLY: Seeing the clinical data and how effective TAKHZYRO was got my attention. It told me that this is a clinically proven treatment to help prevent HAE attacks, and that gave me the confidence to start.

JACK: For me, taking TAKHZYRO once every two weeks means it's not something I need to think about often. Plus, it's subcutaneous, which means it's injected under the skin, not in the vein. That feels manageable for me.

ANDREW: The actual injection takes about a minute, and then I'm free from thinking about my next dose for a few weeks.

SORAYA: I can inject myself, and it takes about a minute. It's an important thing I can do for myself to help reduce the frequency and severity of my HAE attacks.

NARRATOR: TAKHZYRO (lanadelumab) is a prescription medicine used to prevent attacks of hereditary angioedema, HAE, in people 2 years of age and older. It is not known if TAKHZYRO is safe and effective in children under 2 years of age. TAKHZYRO may cause serious side effects, including allergic reactions. Call your healthcare provider or get emergency help right away if you have any of the following symptoms: wheezing, difficulty breathing, chest tightness, fast heartbeat, faintness, rash, and/or hives.

NARRATOR: The most common side effects seen with TAKHZYRO were injection site reactions (pain, redness, and bruising), upper respiratory infection, headache, rash, dizziness, diarrhea, and muscle aches. These are not all the possible side effects of TAKHZYRO. For more information, ask your healthcare provider or pharmacist. You may report side effects to FDA at 1-800-FDA-1088. TAKHZYRO has not been studied in pregnant or breastfeeding women. Talk to your healthcare provider about the risk of taking TAKHZYRO if you are pregnant, plan to be pregnant, are breastfeeding, or plan to breastfeed.

NARRATOR: Talk to your healthcare provider about TAKHZYRO, the only preventive HAE treatment you take as a subcutaneous injection just once every two weeks.

View a real patient case study

Hear from a patient who started TAKHZYRO after learning that their frequent HAE attacks were potentially preventable.

See Study

Explore safety profile

See safety information established in the clinical trials.

See Safety Profile

References: 1. Takhzyro. Prescribing information. Dyax Corp; 2022. 2. Banerji A, Bernstein JA, Johnston DT, et al; HELP OLE Investigators. Long-term prevention of hereditary angioedema attacks with lanadelumab: the HELP OLE study. Allergy. 2022 Mar;77(3):979-990. 3. Cinryze. Prescribing information. Takeda Pharmaceuticals; 2021. 4. Haegarda. Prescribing information. CSL Behring LLC; 2020. 5. Orladeyo. Prescribing information. BioCryst Pharmaceuticals, Inc; 2020. 6. Banerji A, Riedl MA, Bernstein JA, et al. Effect of lanadelumab compared with placebo on prevention of hereditary angioedema attacks: a randomized clinical trial. JAMA. 2018;320(20):2108-2121. doi:10.1001/jama.2018.16773 7. Data on file, SHP643-066, Shire Inc. 8. Data on file, TAK743-098, Takeda Pharmaceuticals. 9 Data on file, TAK743-301, Takeda Pharmaceuticals USA, Inc.