EMA CHMP June 2026: six medicines advance, Tavneos revoked, and broad indication extensions

At its June 2026 meeting, the CHMP recommended six medicines for approval (Aujemflu influenza vaccine for adults 50+, Hopledo for Parkinson’s, Onswik for type 2 diabetes) and two biosimilars (Denosumab Ascend, Nylaspeg); Daybu passed re-examination with a restricted Rett syndrome indication. It issued negative opinions for Tacquell, Yartemlea and Xervyteg. The CHMP also endorsed extensions of indication for 12 medicines (including Imvanex to ages 2+, and Datroway, Jaypirca, Leqvio, MenQuadfi, Opzelura, Orladeyo, Rezolsta, Rinvoq, Stelara, Symtuza, Tecvayli). Withdrawals were made for DuoResp Spiromax and BiResp Spiromax extensions. Start of referral on Rifadin due to excipient concerns; Tavneos’ marketing authorisation was revoked after review. Other updates include Fluenz can be administered by non-healthcare professionals under supervision, Ixchiq extension to high-risk 12+, and including Mounjaro data in product information without a new indication. CHMP statistics noted 6 positive opinions on new medicines, 3 negative opinions, 13 positive opinions on extensions, and 0 withdrawals for new medicines this year.