PharmacovigilanceOfficial

ANSM allows community specialists to prescribe and renew five JAK inhibitors

🇫🇷 ANSM · Thu 22 Oct 2026

From 22 October 2026, five JAK inhibitors for chronic inflammatory diseases can be started and renewed in community practice by the relevant specialists, France's regulator says.

France's medicines agency ANSM has changed the prescribing conditions for Janus kinase (JAK) inhibitors used in chronic inflammatory diseases. From 22 October 2026, five products can be prescribed initially, and renewed, in community practice ("en ville") by the specialist physicians concerned.

The medicines covered are tofacitinib, Olumiant (baricitinib), Rinvoq (upadacitinib), Jyseleca (filgotinib) and Cibinqo (abrocitinib). They are used across rheumatology, gastroenterology, dermatology and allergology.

The indications named by ANSM include rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, polyarticular juvenile idiopathic arthritis, ulcerative colitis, Crohn's disease, atopic dermatitis and alopecia areata. The list in the available text is cut off after a further arteritis indication.

ANSM's summary of the notice says the change comes with reinforced pharmacovigilance surveillance requirements, reflecting continuing safety concerns with the class. The available text does not set out those requirements or the previous prescribing rules, so teams should read the full notice for details.

What it means for your team

  • Pharmacovigilance teams should check the full ANSM notice for the reinforced surveillance requirements attached to the new prescribing conditions.
  • Market-access and medical affairs teams should review how the change to community prescribing and renewal affects the five named products in France.
  • Regulatory teams should confirm whether product information or risk-communication materials for these JAK inhibitors need updating in France.

Official source: ANSM ↗

Article written by VigiEye from the official source (ANSM). AI-assisted; check the source before acting.

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