The Committee for Medicinal Products for Human Use’s April 2026 session covered significant ground, making fourteen positive decisions in four days. The outcomes have direct implications for lifecycle managers and regulatory teams across the EU.
The European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP), responsible for evaluating and recommending medicines for approval across the EU, had its monthly meeting on 20-23 April 2026. At this session, the CHMP delivered an active set of outcomes: five new medicines recommended for approval and nine existing medicines recommended for extensions of their approved uses.
The new medicines are as follows:
- Cenrifki (tolebrutinib), used for non-relapsing secondary progressive multiple sclerosis. The recommendation is based on the Phase 3 HERCULES clinical trial. However, liver injury is an identified safety risk
- Itvisma (onasemnogene abeparvovec), a gene therapy aimed at 5q spinal muscular atrophy by Novartis. Gene therapies remain relatively rare, but the category is growing at the EMA
- Redemplo (plozasiran), used for rare, familial chylomicronaemia syndrome. A first medicine in this area addressing a high unmet medical need, it works through a mechanism called RNA interference
- Rexatilux (ranibizumab), a biosimilar for sight-threatening eye disease, and Palbociclib Viatris (palbociclib), a generic medicine for breast cancer. Both represent the more accessible end of the medicines landscape, where the aim is now to make the existing treatments more accessible and affordable
Beyond new approvals, the Committee also recommended expanded uses for nine already-authorised medicines: Agamree, Aquipta, Crysvita, Comirnaty, Inaqovi, Opdivo, Privigen, Skyrizi and Venclyxto. For regulatory affairs professionals, this means updated product information, including the summary of product characteristics (SmPCs), the patient information leaflet (PIL) and the risk management plan (RMP), will follow for each of these products.
Not all decisions were positive. The Committee did not recommend extending the use of Opdualag (nivolumab/relatlimab) in patients with advanced melanoma with the protein PD-L1 levels of 1% or higher. However, it agreed that the data submitted should still be included in the product information, so that healthcare professionals can see the full evidence picture. This may be particularly valuable for healthcare professionals treating patients with PD-L1 levels below 1%.
Finally, two applicants withdrew their applications: Viokat for Prader-Willi syndrome and Pluvicto for prostate cancer. Withdrawal of an application is a standard option available to applicants at any point during the procedure. The EMA has offered Questions and Answers documents regarding the withdrawal of these two applications.
Regulatory affairs professionals should monitor the EMA website for the publication of the April meeting minutes, expected in the coming weeks, as well as the European Public Assessment Reports for the newly recommended medicines. For products with extended indications, updated SmPCs, PILs and RMPs should be anticipated ahead of the EC’s final decisions, expected within the next few months. The agenda and CHMP statistics for this session can be found on the EMA website.
