EMA’s human medicines committee (CHMP) recommended five medicines for approval at its April 2026 meeting.
The committee recommended granting a marketing authorisation for Cenrifki (tolebrutinib), for the treatment of non-relapsing secondary progressive multiple sclerosis, a disease of the brain and spinal cord in which inflammation destroys the protective covering around nerves and the nerves themselves.
The CHMP recommended granting a marketing authorisation for the gene therapy medicine Itvisma (onasemnogene abeparvovec), for the treatment of spinal muscular atrophy, a rare, serious inherited disease that causes weakness and wasting of the muscles.
The CHMP adopted a positive opinion for Redemplo (plozasiran) to treat adults with familial chylomicronaemia syndrome, a rare inherited disease that prevents the body from breaking down lipids (fats). This medicine provides a new treatment option for patients with a high unmet medical need. See more details in the news announcement in the grid below.
The committee recommended granting a marketing authorisation for Rexatilux (ranibizumab), a biosimilar medicine for the treatment of several eye diseases causing vision impairment.
A generic medicine, Palbociclib Viatris (palbociclib), received a positive opinion for the treatment of breast cancer.
The committee recommended extensions of indication for nine medicines that are already authorised in the European Union (EU): Agamree, Aquipta, Crysvita, Comirnaty, Inaqovi, Opdivo, Privigen, Skyrizi and Venclyxto.
An application for an initial marketing authorisation was withdrawn. Viokat (diazoxide choline) was developed for the treatment of hyperphagia, extreme hunger that cannot be satisfied, in people with Prader-Willi syndrome, a genetic condition that affects growth, development and behaviour.
The application for a new use of Pluvicto (lutetium (177Lu) vipivotide tetraxetan), a medicine to treat cancer of the prostate, to treat adults with PSMA-positive mCRPC who have no or mild symptoms, after their cancer has worsened despite treatment with a hormone blocking medicine, was withdrawn.
Question-and-answer documents on the withdrawal of these two applications are available in the grid below.
The CHMP has finalised its assessment of an application to extend the use of Opdualag (nivolumab/relatlimab) to include the treatment of advanced melanoma, a type of skin cancer that has spread or cannot be surgically removed, with PD-L1 levels of 1% or higher. PD-L1 is a protein produced by some cancer cells. Although EMA did not recommend this use, it agreed that relevant data submitted with the application be included in the medicine’s product information, so that healthcare professionals have access to up-to-date data on the effects of Opdualag in patients with advanced melanoma with PD-L1 levels below 1%.
For more information, see the question-and-answer document in the grid below.
The agenda of the April 2026 CHMP meeting is published on EMA's website. Minutes of the meeting will be published in the coming weeks.
Key figures from the April 2026 CHMP meeting are represented in the graphic below.
Key figures from the April 2026 CHMP meeting are represented in the graphic below.
April 2026 statistics - monthly and cumulative figures for CHMP opinions and withdrawn applications:
5 positive opinions on new medicines: 1 new non-orphan medicine, 2 orphan medicines, 1 biosimilar and 1 generic, hybrid or informed consent medicine. Total in 2026: 28
0 negative opinions on new medicines. Total in 2026: 0
10 positive opinions on extensions of therapeutic indication. Total in 2026: 39
1 withdrawn applications for new medicines. Total in 2026: 3
tolebrutinib
Sanofi Winthrop Industrie
Treatment of non-relapsing secondary progressive multiple sclerosis (nrSPMS) in adults
onasemnogene abeparvovec
Novartis Europharm Limited
Treatment of 5q spinal muscular atrophy (SMA)
This medicine was designated an orphan medicine
plozasiran
Arrowhead Pharmaceuticals Ireland Limited
Treatment of familial chylomicronaemia syndrome (FCS)
This medicine was designated an orphan medicine
ranibizumab
Intas Third Party Sales 2005 S.L.
Treatment of adults with neovascular (wet) age-related macular degeneration (AMD), visual impairment and other retinopathies
palbociclib
Viatris Limited
Treatment of breast cancer
vamorolone
Santhera Pharmaceuticals (Deutschland) GmbH
atogepant
Abbvie Deutschland GmbH & Co. KG
COVID-19 mRNA vaccine
BioNTech Manufacturing GmbH
burosumab
Kyowa Kirin Holdings B.V.
decitabine / cedazuridine
Otsuka Pharmaceutical Netherlands B.V.
nivolumab
Bristol-Myers Squibb Pharma EEIG
human normal immunoglobulin
CSL Behring GmbH
risankizumab
Abbvie Deutschland GmbH & Co. KG
venetoclax
Abbvie Deutschland GmbH & Co. KG
diazoxide choline
Soleno Therapeutics Europe Limited
Treatment of adult and paediatric patients with Prader-Willi syndrome (PWS)
This medicine was designated an orphan medicine
lutetium (177Lu) vipivotide tetraxetan
Novartis Europharm Limited