FDA approves 150 mg oral pellet formulation of Orladeyo for hereditary angioedema
BioCryst Pharmaceuticals announced that the U.S. Food and Drug Administration approved a 150 mg oral pellet version of berotralstat (Orladeyo) for prophylaxis of hereditary angioedema in patients aged 12 years and older. The pellet adds a second dosage form to the existing capsule, which was first approved in December 2020, and is intended for patients who have difficulty swallowing or prefer a non‑capsule option. CEO Charlie Gayer said the approval expands personalized treatment choices. Shares in BioCryst rose about 2 % in pre‑market trading following the announcement.
Why it matters
The new pellet formulation gives BioCryst an additional product line that could increase market penetration among adolescents and adults who prefer a sprinkle‑type dosage, potentially boosting future sales (the company noted a share price rise of 2 % in pre‑market trading).
Key facts
- 1The FDA approved a 150 mg oral pellet formulation of berotralstat (Orladeyo) for prophylaxis of hereditary angioedema in patients aged ≥ 12 years. hcplive.com
- 2The approval adds a second dosage form to the existing 150 mg capsule that was first approved in December 2020. hcplive.com
- 3BioCryst submitted the pellet through a supplemental New Drug Application and the FDA based its decision on chemistry, manufacturing, and controls information plus safety and tolerability data comparing pellets with capsules. hcplive.com
- 4Efficacy for the 150 mg dose is derived from capsule studies that showed a mean attack‑rate reduction of 91 % at 96 weeks and an 88 % drop in rescue medication use. hcplive.com
- 5Shares of BioCryst rose about 2 % in pre‑market trading after the announcement. rttnews.com
- 6Charlie Gayer, president and chief executive officer of BioCryst, said the approval strengthens the company’s ability to provide personalized treatment choice. hcplive.com
Summary written by AlphAI AI Desk from 2 of 2 sources. Not investment advice. Figures are as stated by the linked sources.