Dive Brief:
- Pharvaris said Wednesday its pill for the rare swelling disorder hereditary angioedema succeeded in a Phase 3 trial, helping to begin relieving symptoms of an attack within 1.28 hours, significantly faster than a placebo.
- The Netherlands-based biotechnology company said it plans on asking the Food and Drug Administration in the first half of 2026 to approve deucrictibant. An extended release formulation of the medication is also in a Phase 3 trial to test whether it can prevent HAE attacks, with data expected next year.
- If approved, deucrictibant would be entering an increasingly competitive market. The first oral HAE drug to relieve attacks, Kalvista’s Ekterly, got an FDA nod this year, while two injectable drugs, including one to relieve attacks, also recently launched.
Dive Insight:
Treatment of HAE began with plasma products designed to replace a protein called C1 that regulates blood vessel dilation, but many of these early products could only be administered intravenously. That began to change in the early 2010s with Firazyr, now sold by Takeda, as the first self-administered injection for HAE attacks.
More medicines designed to relieve symptoms of attacks or reduce their frequency have been introduced in the years since. However, 2025 broke new ground with the approval of three drugs: Ekterly, and the preventive shots Andembry from CSL and Dawnzera from Ionis Pharmaceuticals.
Ekterly’s launch pointed to strong demand for an oral drug. Sales of $13.7 million for the third quarter of 2025 well exceeded Leerink Partners’ forecast of $4 million. In assessing the deucrictibant data, Leerink analyst Joseph Schwartz wrote “the market is very receptive to new options in the HAE space.”
”We continue to believe that the HAE market is large enough for multiple players, especially as it continues to expand with the entrance of new options,” Schwartz wrote.
On its primary endpoint, time to onset of symptom response, deucrictibant’s median 1.28 hours is numerically better than Ekterly’s 1.79 hours for its FDA-approved first dose, Schwartz added, although the two drugs haven’t been tested head-to-head. More impressive, he wrote, was the 11.95 hours median time to complete resolution of symptoms for deucrictibant, a measure on which Ekterly took more than 24 hours.
Stifel analyst Paul Matteis, who covers Kalvista, said the differences in effectiveness might not necessarily drive patients to switch once they have begun taking Ekterly, however.
“If you look historically at the on demand market, subtle differences in efficacy haven't really been the determinant of majority share,” Matteis wrote. Within a few months, Kalvista penetrated the market by about 10% and “will have the opportunity to entrench itself further” before deucrictibant might gain approval.
