EMA’s CHMP May 2026 meeting recommended eight new medicines, extended indications for 13 therapies, issued one negative opinion, noted two withdrawals, and approved oral Wegovy for obesity management.
By: Regulatory Desk
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded its May 2026 meeting with a broad set of regulatory actions. The committee adopted positive opinions on eight new medicines, issued one negative opinion, recommended extensions of therapeutic indications for 13 authorised products, noted two application withdrawals, and endorsed a new oral formulation of Wegovy for weight management.
Eight New Medicines Recommended
The CHMP recommended approval of eight medicines spanning respiratory disease, rare genetic disorders, oncology, metabolic health, cardiovascular prevention, and ophthalmology.
Jascayd (nerandomilast): For idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF), both life threatening conditions marked by irreversible lung scarring and progressive respiratory decline. MAH: Boehringer Ingelheim.
Vijoice (alpelisib): Conditional approval for PIK3CA related overgrowth spectrum (PROS), a group of rare disorders characterised by uncontrolled tissue growth. This is the first targeted therapy for PROS in the EU. MAH: Novartis.
Boey (trenibotulinumtoxinE): For temporary improvement of moderate to severe glabellar lines in adults when these have a significant psychological impact. MAH: Galderma.
Etcamah (camizestrant): For locally advanced or metastatic breast cancer with ESR1 mutations, offering a targeted option for a defined subgroup. MAH: AstraZeneca.
Ablymico (liraglutide): Hybrid approval for weight management, combining reference product data with new evidence. MAH: Zentiva.
Liraglutide STADA (liraglutide): Hybrid approval for type 2 diabetes insufficiently controlled with diet and exercise. MAH: STADA Arzneimittel.
Colchicine AGEPHA Pharma (colchicine): Hybrid approval for secondary prevention of atherothrombotic events in adults with stable coronary disease. MAH: AGEPHA Pharma.
Vislyfa (ranibizumab): Biosimilar approved for retinal diseases causing vision impairment, including age related macular degeneration. MAH: Biocon Biologics.
Hybrid applications rely partly on data from authorised reference products and partly on new clinical evidence, enabling broader access to established therapies.
Negative Opinion
The committee recommended not granting marketing authorisation for Deqtynet (copper 64 oxodotreotide), a diagnostic PET agent for well differentiated neuroendocrine tumours. The CHMP concluded that the available evidence did not sufficiently demonstrate clinical benefit.
Indication Extensions
Positive recommendations were issued for 13 medicines already authorised in the EU, including Braftovi, Enhertu, Erbitux, Fasenra, Hetronifly, Iclusig, Keytruda, Maviret, Padcev, Palynziq, Sogroya, Tepkinly, and Trodelvy. These extensions broaden therapeutic reach across oncology, immunology, infectious disease, and metabolic conditions.
Withdrawals
Two applications for initial marketing authorisation were withdrawn by sponsors:
Orblid (bevacizumab): Proposed for hereditary haemorrhagic telangiectasia.
Veblocema (infliximab): Proposed for rheumatoid arthritis, Crohn’s disease, and ulcerative colitis.
Withdrawals typically reflect strategic decisions to generate additional data or reassess regulatory pathways.
Wegovy Oral Formulation
A major highlight was the CHMP’s recommendation to extend the marketing authorisation for Wegovy (semaglutide) to include a daily oral tablet formulation.
Clinical significance: First oral GLP 1 therapy recommended in the EU for chronic weight management.
Indication: Adults with obesity, or overweight adults with at least one weight related comorbidity, alongside diet and physical activity.
Impact: Provides a needle free alternative to weekly injections, potentially improving adherence and expanding patient access.
Regulatory Significance
The May 2026 CHMP meeting underscores the committee’s dual role in advancing innovation while safeguarding standards. Eight new medicines, including first in class therapies for PROS, pulmonary fibrosis, and obesity, represent meaningful progress across rare diseases, oncology, cardiometabolic health, and ophthalmology. At the same time, the negative opinion and application withdrawals highlight the EMA’s insistence on robust evidence.
The oral Wegovy recommendation is particularly noteworthy, marking the EU’s first oral GLP 1 therapy for obesity care and expanding patient access to this transformative drug class.
Following CHMP recommendations, the European Commission will review the opinions before issuing final legally binding decisions applicable across EU member states.
Reference