Icatibant Acetate

KalVista Pharmaceuticals gained FDA approval of its plasma kallikrein inhibitor Ekterly (sebetralstat) for the treatment of acute attacks of hereditary angioedema (HAE), nearly three weeks after the agency had been scheduled to make a decision. The clearance, announced Monday, makes Ekterly the first oral on-demand treatment for HAE.Prior to the approval of the oral drug, all on-demand HAE treatments authorised in the US required intravenous or subcutaneous administration, which KalVista CEO Ben Palleiko said are "really burdensome" for patients. He noted that Ekterly's route of administration and size "enables people to treat attacks the moment symptoms begin, wherever they are."Ekterly is approved for the treatment of acute attacks of HAE in adult and pediatric patients aged 12 years and older based on findings from the Phase III KONFIDENT trial. Results showed that the drug achieved significantly faster symptom relief, reduction in attack severity and attack resolution than placebo.The FDA had been scheduled to make a decision on approval of Ekterly by June 17, but said last month that it needed further time to evaluate the application due to a "heavy workload and limited resources." News of the authorisation — which some reports suggested FDA Commissioner Marty Makary had previously tried to stop — sent KalVista's shares up nearly 19% on Monday.Ahead of approval, Needham analyst Serge Belanger said that KalVista would price Ekterly at a slight premium to Takeda's injectable on-demand treatment Firazyr (icatibant), which costs $11,000 per unit. Meanwhile, Jonathan Wolleben of Citizens Bank estimates peak US sales of Ekterly at around $250 million, suggesting that the early launch could exceed expectations due to potential premium pricing and rapid adoption.

Dive Brief:After a delay due to resource constraints, the Food and Drug Administration on Monday approved Kalvista Pharmaceuticals pill Ekterly to treat swelling attacks in people with the rare disorder hereditary angioedema.Ekterly is the first oral drug to treat hereditary angioedema, or HAE, attacks, competing with shots like Firazyr from Takeda and Ruconest from Pharming. Analysts have estimated Ekterly, Kalvistas first marketed drug, could bring in $600 million a year in U.S. sales at its peak.The FDA delayed the decision beyond its June 17 deadline, Kalvista said, because of a heavy workload and limited resources. While Kalvista awaited its decision, the FDA granted approval to another HAE drug, CSLs Andembry,a preventive shot that wont compete directly with Ekterly.Dive Insight:Kalvista set a price of $16,720 per dose, which consists of two 600 milligram tablets of Ekterly, known scientifically as sebetralstat. A company spokesperson stated Kalvista priced Ekterly competitively with existing therapies, reflecting the innovation it brings to the HAE community, noting that its the first new drug in more than a decade.Under the FDAs approval, people experiencing a HAE attack can take a second dose within three hours if they dont get symptom relief, while people taking Firazyr must wait six, a protocol that could give Ekterly a competitive advantage, Stifel analyst Paul Matteis wrote in a note to clients. Moreover, people using Firazyr and Ruconest must receive training before they can self-inject.The drug won approval based on a trial of 110 people,which found that people who took Ekterlyafter an attack achieved symptom relief in a median of two hours following a dose within a 12-hour window in which the drugs effectiveness was measured. Fewer than 50% of people who took a placebo in the trial experienced symptom relief within 12 hours.More HAE attacks were resolved in people who took Ekterlywithin 24 hours, at about 50% compared to 27% in those who took placebo.Kalvista shares rose 24% in early trading, recovering all of the losses following the FDAs delay.Matteis took an optimistic view of the drug, writing that Ekterlys injectable-like efficacy has the potential to take a meaningful share, and potentially grow, the on-demand HAE market, which has remained relatively stable. '