chmp Arkiv - NHTA https://nhta.com/tag/chmp/ Mon, 27 Apr 2026 16:00:43 +0000 en-US hourly 1 https://wordpress.org/?v=7.1 https://nhta.com/wp-content/uploads/2025/06/favicon-150x150.png chmp Arkiv - NHTA https://nhta.com/tag/chmp/ 32 32 CHMP issues positive opinion for five new medicines and nine extensions https://nhta.com/chmp-issues-positive-opinion-for-five-new-medicines-and-nine-extensions/ Fri, 24 Apr 2026 12:54:00 +0000 https://nhta.com/chmp-issues-positive-opinion-for-five-new-medicines-and-nine-extensions/ EMA’s CHMP has published its meeting highlights from 20–23 April 2026. Key takeaways from the update – Five new medicines were recommended for approval. – Nine medicines were recommended for extensions of their therapeutic indications. Examples of new medicine recommendations mentioned – Cenrifki (tolebrutinib): recommended for marketing authorisation for the treatment of non-relapsing secondary progressive multiple sclerosis....

Indlægget CHMP issues positive opinion for five new medicines and nine extensions blev først udgivet på NHTA.

]]> EMA’s CHMP has published its meeting highlights from 20–23 April 2026.

Key takeaways from the update
– Five new medicines were recommended for approval.
– Nine medicines were recommended for extensions of their therapeutic indications.

Examples of new medicine recommendations mentioned
– Cenrifki (tolebrutinib): recommended for marketing authorisation for the treatment of non-relapsing secondary progressive multiple sclerosis.
– Itvisma (onasemnogene abeparvovec): recommended for marketing authorisation as a gene therapy for the treatment of spinal muscular atrophy.

The EMA page also lists sections covering CHMP statistics, recommendations for a new biosimilar medicine and a new generic medicine, and notes on withdrawals and other updates.

Read more at https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-20-23-april-2026

Indlægget CHMP issues positive opinion for five new medicines and nine extensions blev først udgivet på NHTA.

]]> CHMP backs five new medicines in March 2026 https://nhta.com/chmp-backs-five-new-medicines-in-march-2026/ Fri, 27 Mar 2026 11:15:14 +0000 https://nhta.com/chmp-backs-five-new-medicines-in-march-2026/ CHMP’s March 2026 meeting delivered a broad set of EU regulatory updates. New medicines recommended for approval (5) Adstiladrin (nadofaragene firadenovec): conditional marketing authorisation for BCG-unresponsive non-muscle invasive bladder cancer with carcinoma in situ (± papillary tumours). Imdylltra (tarlatamab): marketing authorisation for relapsed extensive-stage small cell lung cancer; described as addressing an unmet medical need....

Indlægget CHMP backs five new medicines in March 2026 blev først udgivet på NHTA.

]]> CHMP’s March 2026 meeting delivered a broad set of EU regulatory updates.

New medicines recommended for approval (5)

  • Adstiladrin (nadofaragene firadenovec): conditional marketing authorisation for BCG-unresponsive non-muscle invasive bladder cancer with carcinoma in situ (± papillary tumours).
  • Imdylltra (tarlatamab): marketing authorisation for relapsed extensive-stage small cell lung cancer; described as addressing an unmet medical need.
  • Joenja (leniolisib): authorisation under exceptional circumstances for APDS in patients ≥12 years and ≥45 kg; incidence estimated at 1–2 per million.
  • Zepzelca (lurbinectedin): maintenance in extensive-stage small cell lung cancer after non-progression following first-line induction.
  • Bopediat (furosemide): paediatric-use marketing authorisation (PUMA); hybrid application.

Other CHMP outcomes

  • 13 medicines received positive opinions for extensions of indication.
  • Hetlioz re-examination: CHMP confirmed refusal of an extension for Smith-Magenis syndrome sleep disturbance.
  • Tecovirimat SIGA: CHMP recommended it should no longer be used for mpox.
  • CHMP adopted a reflection paper on a tailored clinical approach in biosimilar development.

Read more at https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-23-26-march-2026

Indlægget CHMP backs five new medicines in March 2026 blev først udgivet på NHTA.

]]>