FILE PHOTO: Logo and flags of Bayer AG are pictured outside a plant of the German pharmaceutical and chemical maker in Wuppertal, Germany August 9, 2019. REUTERS/Wolfgang Rattay
FRANKFURT (Reuters) – Bayer on Friday won an endorsement from the European Union’s drug regulator for its prostate cancer drug darolutamide, putting it on track for approval, as it takes on rival products by Pfizer and Johnson & Johnson.
An expert panel at the European Medicines Agency (EMA) recommended the drug for approval for use in early-stage prostate cancer that does not respond to hormonal therapy to slow its spread to other body parts, the German drugmaker said on Friday.
The European Commission, which has the final word on drug approval in the EU, typically adopts the EMA experts’ view.
The drug, which won U.S. marketing approval in July 2019, was developed by Finland’s Orion, which sold certain rights to it in a collaboration deal with Bayer in 2014.
Competing with Xtandi by Astellas and Pfizer as well as J&J’s Erleada, Bayer hopes the drug will generate annual peak sales of at least 1 billion euros ($1.13 billion).
Reporting by Ludwig Burger; editing by David Evans