FDA lifts hold on Pharvaris HAE drug

2024-01-22

临床3期上市批准并购申请上市

The U.S. FDA has lifted the clinical hold on Pharvaris' IND for a new oral prophylactic treatment for hereditary angioedema (HAE), clearing the path for phase 3 trials.

The agency placed clinical studies of Switzerland-based Pharvaris' deucrictibant, a bradykinin B2 receptor antagonist, on hold back in August 2022. The reason for the hold was not shared by Pharvaris, but the company committed to working with the FDA to get both versions of the drug — one for on-demand use and one for preventative use — back on track.

In June 2023, the FDA removed the hold on deucrictibant for the on-demand treatment, following a review of data from a preplanned interim analysis of a 26-week rodent toxicology study. Now, with full data in hand, the FDA has lifted the remaining hold, allowing Pharvaris to resume its phase 2 proof-of-concept study and head into the phase 3 study of deucrictibant extended-release tablets for the prophylactic treatment of HAE attacks.

Hereditary angioedema is a rare, inherited disorder characterized by recurrent episodes of severe swelling.

Takeda inherited two injectable HAE drugs during its 2018 takeover of Shire. Firazyr, approved in 2011, is used on-demand during attacks, and Takhzyro, approved in 2018, is taken every two weeks as a preventative. CSL Behring has its drug, a once-monthly prophylactic injectable known as garadacimab, currently in the hands of regulators.

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