#Ec-Decision-November-2026

2 stories

Regulatory September 20, 2026 · View digest

Novartis Cosentyx (Secukinumab, IL-17A Inhibitor Monoclonal Antibody) Receives Positive EU CHMP Opinion in Polymyalgia Rheumatica (PMR); First IL-17 Inhibitor in Class for This Steroid-Refractory Population

Novartis (NYSE: NVS; SIX: NOVN) announced Friday September 18, 2026 that the EMA's CHMP adopted a positive opinion recommending EU marketing authorization for Cosentyx (secukinumab, a fully human IgG1 monoclonal antibody against interleukin-17A) for the treatment of adults with polymyalgia rheumatica (PMR) who have had an inadequate response to steroids or who experience relapse during steroid taper. Upon EC approval, Cosentyx would be the first IL-17A inhibitor licensed in Europe for PMR — a common inflammatory rheumatic disease in adults over 50 with limited advanced treatment options beyond long-term steroids (which carry significant morbidity). The recommendation is anchored on the REPLENISH Phase 3 trial: all primary and secondary endpoints were met across both Cosentyx 300 mg and 150 mg treatment arms, showing doubled sustained remission rates and steroid-sparing benefit versus placebo, with safety consistent with the established Cosentyx profile. European Commission decision is expected by November 2026. Cosentyx generated approximately $6.4 billion in 2025 global sales across its 10+ approved indications.

Regulatory September 19, 2026 · View digest

Zealand Pharma Zeydovio (Glepaglutide, Long-Acting GLP-2 Receptor Agonist Peptide) Receives Positive EU CHMP Opinion for Adult Short Bowel Syndrome; First Major SBS Advance in Europe in Over a Decade

Zealand Pharma (NASDAQ: ZEAL; NASDAQ Copenhagen: ZEAL) announced Friday September 18, 2026 that the EMA's Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recommending marketing authorization for Zeydovio (glepaglutide, a long-acting next-generation GLP-2 receptor agonist peptide) for the treatment of adults with short bowel syndrome (SBS). The recommendation is anchored on the registrational Phase 3 EASE-1 trial: 65.7% of patients on glepaglutide achieved at least a 20% reduction in parenteral support volume versus 38.9% on placebo, with approximately 1 in 7 patients weaning off parenteral support entirely at 24 weeks. Zeydovio will be supplied as a 10 mg solution for injection in a pre-filled pen. This is the first major CHMP advance in SBS in more than a decade — the current European standard-of-care GLP-2 analog teduglutide (Takeda's Revestive) has been the only GLP-2 in the EU market since 2012. The European Commission decision is expected within approximately 67 days (mid-November 2026 timeframe). Zealand retains full commercial rights in Europe. Glepaglutide is also under FDA review with a U.S. PDUFA action date targeted for early 2027.