CHMP recommends label expansions for 12 medicines
- Sponsor
- AbbVie; J&J; Daiichi Sankyo; Novartis; Lilly; Incyte; Bavarian Nordic; Sanofi
- Drug
- Rinvoq, Stelara, Tecvayli, Datroway, Leqvio, Jaypirca, Opzelura, Imvanex, Menquadfi, Rezolsta, Symtuza · upadacitinib, ustekinumab, teclistamab, datopotamab deruxtecan, inclisiran, pirtobrutinib, ruxolitinib, modified vaccinia Ankara, meningococcal vaccine, darunavir/cobicistat, darunavir/cobicistat/emtricitabine/tenofovir alafenamide
- Indication
- multiple — see source for per-drug detail
EMA's CHMP issued positive opinions for therapeutic-indication extensions on 12 already-authorised medicines at its 22-25 June 2026 meeting, including expansions for Rinvoq, Stelara, Tecvayli, Datroway, Leqvio, Jaypirca, Opzelura, Imvanex, Menquadfi, Rezolsta, and Symtuza.
What this means
Europe's drug regulator endorsed 12 expanded uses for already-approved medicines at this week's review meeting — meaning these drugs can be marketed in Europe for additional patient groups or conditions once the formal authorisation follows. The list spans immunology (Rinvoq, Stelara), HIV (Rezolsta, Symtuza), oncology (Datroway, Jaypirca, Tecvayli), cardiovascular medicine (Leqvio), dermatology (Opzelura), and several vaccines. Many of these drugs have parallel US approvals that already track in our coverage; the EU extensions add to their global label.
From the source
At the 22-25 June 2026 meeting of EMA's Committee for Medicinal Products for Human Use (CHMP), 12 medicines received positive opinions for extensions of therapeutic indication:
Imvanex (modified vaccinia Ankara, Bavarian Nordic) — vaccine indication extension. Datroway (datopotamab deruxtecan, Daiichi Sankyo / AstraZeneca) — oncology indication extension. Jaypirca (pirtobrutinib, Eli Lilly) — haematologic malignancy indication extension. Leqvio (inclisiran, Novartis) — cardiovascular / lipid indication extension. Menquadfi (meningococcal conjugate vaccine, Sanofi) — vaccine indication extension. Opzelura (ruxolitinib cream, Incyte) — dermatology indication extension. Rezolsta (darunavir/cobicistat, Janssen-Cilag) — HIV indication extension. Rinvoq (upadacitinib, AbbVie) — immunology indication extension. Stelara (ustekinumab, Janssen-Cilag) — immunology indication extension. Symtuza (darunavir/cobicistat/emtricitabine/tenofovir alafenamide, Janssen-Cilag) — HIV indication extension. Tecvayli (teclistamab, Janssen-Cilag) — multiple myeloma indication extension.
2026 year-to-date: 71 indication-extension opinions (12 at this meeting).
Reproduced from EMA News · view original · public domain or open-licensed government work