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FDA approves BioCryst's Orladeyo for reducing hereditary angioedema attacks

Published on 04/12/20 at 11:19am

BioCryst has scored FDA for its therapy Orladeyo (berotralstat) for reducing or preventing hereditary angioedema (HAE) attacks in patients over the age of 12, marking the first approval in the US of an orally administered non-steroidal treatment in this indication.

After 24 weeks of treatment, Phase 3 data showed that the drug generated a “significant reduction” in attacks experienced by trial participants with HAE. This benefit was sustained for a full 48 weeks, bring the average frequency of attacks experienced by patients from 2.9 attacks per month to an average of 1.0 attacks over the same period.

According to long-term trial data, the average frequency of attacks in patients who had taken Orladeyo for 48 weeks was found to be 0.8 per month.

“Patients and physicians acknowledge that HAE treatments can add a burden to patients’ lives.  As an oral, once-daily option, Orladeyo can provide significant attack reduction and lessen the burden associated with injections and infusions,” said Dr Marc Riedl, an investigator on the trial and Professor of Medicine and Clinical Director of the US Hereditary Angioedema Association Center at the University of California.

He added: “With this new treatment option, physicians and patients can continue to have collaborative discussions to choose the treatment that meets each patient’s needs, life circumstances and preferences.”

Matt Fellows

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