Significant attack reduction seen in 2 studies
First study led to TAKHZYRO FDA approval
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 in the 6.5-month study, people had
87%
FEWER ATTACKS
compared with placebo
with an average monthly attack rate of 0.3 for people taking TAKHZYRO vs 2.0 for people taking placebo
During the last 4 months of the clinical study, nearly
8 OUT OF 10 (77%)
People had ZERO attacks
compared with 3% taking placebo
In this study, 44% of people taking TAKHZYRO had zero attacks for the entire 6.5-month study compared with 2% of people taking placebo.
People also had 83% fewer moderate or severe attacks and 87% fewer attacks that needed acute treatment compared to placebo.
While supportive of the main findings, the results above were not the primary focus of the clinical study. It was not designed to measure the percentage of people who had zero attacks after 2.5 months of treatment through the end of the study.
All data presented are for TAKHZYRO 300 mg every 2 weeks unless otherwise indicated.
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.
On average in the 2.5-year study, people had
87%
FEWER ATTACKS
compared with baseline
More than
8 OUT OF 10 (82%)
people had ZERO attacks
for at least 6 months
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.
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 the long-term, open-label clinical study.
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.