TAKHZYRO CLINICAL STUDY RESULTS
Freedom from HAE attacks: Some people experienced up to one year attack free
TAKHZYRO was evaluated in two hereditary angioedema (HAE) studies: The first study led to FDA approval of TAKHZYRO, and the second was completed after FDA approval. The results speak for themselves—read on.
First study leading
to
FDA approval
of TAKHZYRO
The 6.5-month clinical study included 125 people diagnosed with HAE aged 12 years and older. The main goal of the study was to evaluate the ability of TAKHZYRO 300 mg every 2 weeks to reduce the frequency of HAE attacks.
On average, people had
fewer attacks
compared with placebo
HAD ZERO
ATTACKS
for the entire 6.5-month
study
compared with 2%
of those
taking placebo
People also had 83% fewer moderate or severe attacks and 87% fewer attacks that needed acute treatment compared to placebo.
Second study
completed after
FDA
approval
The 2.5-year open-label extension clinical study included 212 people diagnosed with HAE aged 12 years and older. The main goal of this study was to evaluate the long-term safety of TAKHZYRO 300 mg every 2 weeks. Patients knew they were receiving TAKHZYRO, which could have influenced the study results.
In this study, people taking TAKHZYRO for an average of 2.5 years had similar results to those in the 6.5-month clinical study.
On average, people had
fewer attacks
compared with baseline
HAD ZERO
ATTACKS
for up to a year
People also had 84% fewer moderate or severe attacks and 93% fewer attacks that needed acute treatment compared with baseline.
Baseline means a person's attack rate before beginning treatment in either the clinical study or the long-term, open-label study.
All data presented are for TAKHZYRO 300 mg every 2 weeks unless otherwise indicated.
Safety results established in one of the
largest prevention studies in HAE
TAKHZYRO may cause serious side effects, including allergic reactions. Call your healthcare provider or get emergency help right away if you have symptoms of an allergic reaction.
Side effects displayed in the following tables occurred in ≥10% of people taking TAKHZYRO.
Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of TAKHZYRO.
For more information, ask your healthcare provider or pharmacist.
The 6.5-month clinical study
Injection site reactions were the most common side effects of TAKHZYRO in the clinical study.
*Included all people treated with TAKHZYRO (300 mg every 2 weeks, 300 mg every 4 weeks, or 150 mg every 4 weeks) in the clinical study.
View Transcript
JACK: TAKHZYRO was studied in one of the longest preventive trials in HAE. Seeing the results gives me confidence that I'm on a treatment that not only works for me, but has been proven in clinical setting to work for others as well.
KELLY: HAE attacks are unpredictable and always will be. Knowing TAKHZYRO has been studied for as long as it was is particularly important because I'm going to have HAE for the rest of my life.
DENNIS: TAKHZYRO has been available since 2018 and doctors have prescribed it over 2500 times.
ANDREW: For me, it's not just the study results of TAKHZYRO that inspire confidence. It's also knowing that I'm on a treatment that's been prescribed to over 2500 people with HAE. It feels good to be a part of that number.
SORAYA: HAE attacks can really interfere with your life. They can happen at any time when you least expect it. The study results of TAKHZYRO tell me I'm doing something to help prevent my HAE attacks today and tomorrow.
NARRATOR: TAKHZYRO (lanadelumab) is a prescription medicine used to prevent attacks of hereditary angioedema, HAE, in people 12 years of age and older. It is not known if TAKHZYRO is safe and effective in children under 12 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 and headache. 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 the 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.
