CHMP issued positive recommendations on 24 April 2026 for four new medicines Cenrifki, Itvisma, Redemplo, and Rexatilux highlighting advances in neurology, rare diseases, metabolic disorders, and ophthalmology, along with a generic approval for Palbociclib Viatris.
Written By: Nikita Jha, BPharm, Samiksha Jadhav BPharm and
Sana Khan BPharm
Reviewed By: Pharmacally Editorial Team
On 24 April 2026, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) issued positive recommendations for four new medicines—Cenrifki, Itvisma, Redemplo, and Rexatilux as part of its monthly meeting outcomes. These recommendations mark a key regulatory milestone preceding formal European Commission approval. They also signal important therapeutic advances across neurology, rare diseases, metabolic disorders, and ophthalmology. The selected medicines reflect a mix of innovative mechanisms, including BTK inhibition, gene therapy, and RNA interference, as well as biosimilar development, with several targeting rare diseases and areas of high unmet clinical need.
In addition, the CHMP issued a positive opinion for Palbociclib Viatris (palbociclib), a generic medicine indicated for the treatment of breast cancer, further supporting expanded patient access to established targeted therapies.
CENRIFKI
Name of the Drug: Cenrifki (Tolebrutinib)
MAH: Sanofi Winthrop Industrie
Class of Drug: Bruton’s tyrosine kinase (BTK) inhibitor
Indication: Treatment of adults with non-relapsing secondary progressive multiple sclerosis (nrSPMS)
Key Trials: HERCULES (NCT04411641): Primary endpoint (delay in confirmed disability progression) met, demonstrating a statistically significant reduction in disability progression compared with placebo.
ITVISMA
Name of the Drug: Itvisma (Onasemnogene Abeparvovec)
MAH: Novartis Europharm Limited
Class of Drug: Gene therapy (AAV9-based SMN1 gene replacement)
Indication: Treatment of 5q spinal muscular atrophy (SMA)
Key Trials: STEER (NCT05089656), STRENGTH (Phase IIIb) (NCT05386680), STRONG (Phase I/II): Primary endpoint met; in STEER, Itvisma demonstrated a statistically significant 2.39-point improvement in HFMSE, with effects sustained over 52 weeks. STEER and STRENGTH also showed clinically meaningful benefit in both treatment-naïve and pre-treated patients.
REDEMPLO
Name of the Drug: Redemplo (Plozasiran)
MAH: Arrowhead Pharmaceuticals Ireland Limited
Class of Drug: Small interfering RNA (siRNA) targeting APOC3
Indication: Treatment of familial chylomicronaemia syndrome (FCS)
Key Trials: PALISADE (Phase III, NCT05089084): The study met its primary endpoint and all multiplicity-controlled key secondary endpoints, demonstrating significant reductions in triglycerides and apoC-III levels, as well as a reduction in the incidence of acute pancreatitis in the pooled dose groups.
REXATILUX
Name of the Drug: Rexatilux (Ranibizumab)
MAH: Intas Third Party Sales 2005 S.L.
Class of Drug: Anti-VEGF monoclonal antibody fragment (biosimilar)
Indication: Neovascular (wet) age-related macular degeneration; visual impairment due to diabetic macular oedema; proliferative diabetic retinopathy; visual impairment due to macular oedema secondary to retinal vein occlusion; and visual impairment due to choroidal neovascularisation
Key Trials: Not publicly disclosed; approval based on comparative biosimilar studies demonstrating equivalence to reference ranibizumab in efficacy, safety, and immunogenicity.
The April 2026 CHMP recommendations highlight a diverse and evolving therapeutic pipeline that reflects major trends in modern drug development. These include advancements in neurodegenerative disease management with Cenrifki, the continued rise of transformative gene therapies such as Itvisma, the growing impact of RNA-based approaches in metabolic disorders as seen with Redemplo, and the expansion of treatment access through biosimilars like Rexatilux. Collectively, these positive opinions underscore a strategic shift toward innovation-driven, precision-focused therapies alongside efforts to improve affordability and accessibility within the European healthcare landscape.
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