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EMA’s CHMP recommends two drugs approved in U.S., rebuffs belumosudil

The negative opinion comes four years after FDA approval

October 17, 2025 8:26 PM UTC

At its October meeting, CHMP recommended two new medicines that FDA approved in August: Brinsupri brensocatib and Wayrilz rilzabrutinib. 

Brinsupri from Insmed Inc. (NASDAQ:INSM) is used to treat non-cystic fibrosis bronchiectasis, an indication the company believes could generate up to $5 billion in peak sales, even without the expansion opportunities it’s exploring...