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
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
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.