Nov 13 (Reuters) – AstraZeneca said on Friday a European medicines committee had backed its hypertension pill baxdrostat, branded as Baxfendy, for marketing authorisation, potentially making it the first drug of its class to reach patients in the European Union.
• The Committee for Medicinal Products for Human Use, or CHMP, recommended baxdrostat for adults whose hypertension is insufficiently controlled by at least two medicines
• If approved, Baxfendy would be the EU’s first and only aldosterone synthase inhibitor, AstraZeneca said. The drug works by blocking the hormone aldosterone, a different approach from older blood pressure treatments
• The CHMP said its recommendation was based on positive results from two late-stage trials
• Baxdrostat is already approved in the US and other countries, while filings are under review in Japan and China
• AstraZeneca acquired baxdrostat as part of its $1.8 billion purchase of CinCor Pharma in 2023
• While final approvals are up to the European Commission, it typically follows the CHMP’s recommendation
(Reporting by Ankita Bora in Bengaluru; Editing by Tasim Zahid)
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