EU panel recommends AstraZeneca’s hypertension drug Baxfendy for marketing authorisation
AstraZeneca said the European Medicines Agency’s human medicines committee issued a positive opinion on Baxfendy (baxdrostat) for adults whose blood pressure remains uncontrolled despite at least two other drugs. The recommendation is based on Phase III trials that showed placebo‑adjusted systolic reductions of about 10 mmHg to 14 mmHg. The drug, already approved in the United States, would become the EU’s first aldosterone synthase inhibitor if the European Commission grants final authorisation. AstraZeneca acquired Baxfendy through its February 2023 purchase of CinCor Pharma.
Why it matters
The positive opinion clears the way for a potential new class of antihypertensive in Europe, expanding AstraZeneca’s revenue base. The European Commission’s decision, expected within 67 days, will determine when the drug can be marketed in the EU.
Key facts
- 1The EMA’s human medicines committee issued a positive opinion recommending EU approval of Baxfendy for adults with uncontrolled hypertension on 13 November 2026. securities.io
- 2Baxfendy is already approved in the United States and other countries. securities.io
- 3Phase III BaxHTN trial (796 patients) showed a 9.8 mmHg placebo‑adjusted reduction in seated systolic blood pressure at 12 weeks for the 2 mg dose. securities.io
- 4Phase III Bax24 trial (218 patients) showed a 14.0 mmHg placebo‑adjusted reduction in 24‑hour ambulatory systolic pressure at 12 weeks for the 2 mg dose. securities.io
- 5AstraZeneca acquired the drug through its February 2023 purchase of CinCor Pharma. securities.io
- 6The European Commission normally issues a binding decision within 67 days of the committee’s recommendation. techtimes.com
Summary written by AlphAI AI Desk from 5 of 5 sources. Not investment advice. Figures are as stated by the linked sources.