CHMP April 2026: Five Approvals Span Gene Therapy to Biosimilar

EMA's Committee for Medicinal Products for Human Use concluded its April 2026 meeting with five positive opinions, a slate that spans gene therapy, RNA-targeted treatment, biosimilar ranibizumab, and a palbociclib generic -- a breadth that signals continued pipeline diversification across modalities and will require EU market access teams to update dossier strategies accordingly.

Among the most consequential recommendations is the positive opinion for Itvisma (onasemnogene abeparvovec), a gene therapy indicated for spinal muscular atrophy. The committee also recommended Cenrifki (tolebrutinib) for non-relapsing secondary progressive multiple sclerosis and adopted a positive opinion for Redemplo (plozasiran) for familial chylomicronaemia syndrome, a rare inherited lipid disorder representing a high unmet medical need. Rexatilux (ranibizumab), a biosimilar for vision-impairing eye diseases, and the generic Palbociclib Viatris (palbociclib) for breast cancer round out the five approvals.

The committee also recommended extensions of therapeutic indication for nine already-authorised medicines: Agamree, Aquipta, Crysvita, Comirnaty, Inaqovi, Opdivo, Privigen, Skyrizi, and Venclyxto. Regulatory affairs leads managing lifecycle strategies for these products should note that updated product information will follow. Separately, two applications were withdrawn: Viokat (diazoxide choline) for hyperphagia in Prader-Willi syndrome, and a new-indication application for Pluvicto (lutetium (177Lu) vipivotide tetraxetan) covering PSMA-positive metastatic castration-resistant prostate cancer patients with no or mild symptoms following progression on hormonal therapy.

A notable procedural outcome involves Opdualag (nivolumab/relatlimab): the CHMP did not recommend extending its use to advanced melanoma with PD-L1 levels of 1% or higher, but agreed that relevant submitted data be incorporated into the product information to ensure healthcare professionals retain access to efficacy and safety data in patients with PD-L1 levels below 1%. QA and regulatory teams should monitor EMA's website, as supporting documents for this meeting are being published on a rolling basis.

Source: EMA CHMP Meeting Highlights, 20-23 April 2026, published 24 April 2026.