The EMA’s human medicines committee has recommended 12 new medicines for approval, including treatments for haemophilia A, rabies and short bowel syndrome.
The recommendations came from the September meeting of the Committee for Medicinal Products for Human Use (CHMP), held from 14 to 17 September. They now go to the European Commission, which makes the final, legally binding decision.
The meeting at a glance
- New medicines recommended: 12
- Also recommended: 2 biosimilars, 2 generics and 11 extensions of indication
- Notable extensions: Including Keytruda, Ocrevus and Cosentyx
- Negative outcome: A refusal for Xervyteg, a faecal microbiota product, was confirmed on re-examination
Selected new medicines
- Frehemgo (denecimig): haemophilia A
- Povofortay (povorcitinib): hidradenitis suppurativa
- VaxRabeo: rabies
- Zeydovio (glepaglutide): short bowel syndrome
Safety reviews
The committee also concluded two safety reviews:
- Ipidacrine: Benefits still outweigh risks, but authorisations will be removed for several conditions and prescribing limited to experienced specialists.
- Sodium oxybate for alcohol dependence (sold as Alcover in Austria and Italy): Benefits still outweigh risks, but new efficacy studies are now a condition of keeping the authorisations.
Why it matters
- A busy pipeline. Twelve new medicines in one meeting points to a strong flow of products into European markets over the coming months.
- Generics and biosimilars. Recommendations for biosimilars and generics support competition and lower prices.
- Usual timing. The European Commission normally issues its decision within about two months of a positive CHMP opinion.
What it means for the supply chain
A positive opinion is the signal for companies to prepare European launches: packaging in local languages, serialisation, distribution agreements and pricing submissions in each country. For wholesalers and hospital buyers, this meeting gives an early view of products likely to arrive in the months ahead.
The bottom line
September’s CHMP meeting adds a dozen new medicines to Europe’s launch pipeline. Expect Commission approvals in the coming weeks, followed by country-by-country launches.
Frequently Asked Questions
What is the CHMP? The European Medicines Agency’s committee that assesses medicines for human use and recommends whether they should be approved.
How many new medicines were recommended? Twelve, plus two biosimilars, two generics and 11 extensions of indication.
Are these medicines approved now? Not yet. The European Commission makes the final decision, usually within about two months.
Was anything rejected? A refusal for Xervyteg, a faecal microbiota product, was confirmed on re-examination.
Sources
| Source | Used for |
|---|---|
| PharmTech regulatory roundup | Meeting outcomes, medicines, safety reviews |
| European Medicines Agency (EMA) meeting highlights | CHMP recommendations |
Additional Resources
| Resource | What you’ll find |
|---|---|
| European Medicines Agency (EMA) | Full meeting highlights and product assessments |
| European Commission – Union Register of medicinal products | Final approval decisions |
| Medicines for Europe | Generic and biosimilar industry information |
| European Federation of Pharmaceutical Industries and Associations (EFPIA) | European pharmaceutical market data |
Data note: Company names were not given for all recommended medicines in available reporting, so they are not listed.