BioCryst wins FDA approval for Orladeyo oral pellets

 BioCryst Pharma (BCRX) announced on Friday that the U.S. Food and Drug Administration (FDA) approved an oral pellet formulation of its best-selling therapy, Orladeyo, as a once-daily preventive option for children with hereditary angioedema, a genetic condition characterized by swelling.

Specifically, the FDA has greenlighted the company’s New Drug Application (NDA) for Orladeyo oral pellets as a prophylactic therapy for patients aged two to 12 years with HAE, according to BioCryst (BCRX).

Orladeyo becomes the first targeted oral prophylactic therapy available for HAE patients aged 2 and above, with the approval, the company said, adding that the oral pellet formulation marked a convenient mode of drug administration for children.

In December 2020, the FDA cleared a capsule version of the drug for prophylaxis of HAE patients 12 years and older, and so far, patients under 12 have had to rely on intravenous or subcutaneously delivered targeted HAE therapies.

https://www.msn.com/en-us/health/other/biocryst-wins-fda-approval-for-orladeyo-oral-pellets/ar-AA1SdEzK