VERTEX PHARMACEUTICALS (IRELAND) LIMITED

CHMP Backs 12 New Medicines, Including First Oral Daily Hidradenitis Suppurativa Option and Earlier-Line Tecvayli

- The EMA's CHMP recommended 12 new medicines for approval at its September 14-17, 2026 meeting, alongside 11 therapeutic indication extensions and two biosimilars. - Povofortay (povorcitinib) became the first oral daily treatment recommended for adults with moderate to severe hidradenitis suppurativa refractory or intolerant to anti-TNF therapy. - Johnson & Johnson's Tecvayli (teclistamab) won support for earlier-line multiple myeloma use, with MajesTEC-3 data showing a 71% reduction in progression risk versus standard of care. - Two initial marketing applications were withdrawn, for apitegromab in 5q spinal muscular atrophy and trilaciclib in extensive-stage small-cell lung cancer, while three negative opinions entered re-examination.