Wayrilz (rilzabrutinib)
OrphanAdditional monitoring
- Region
- 🇪🇺 EU
- Active substance
- rilzabrutinib
- Company
- Sanofi B.V.
- Status
- Authorised
- Therapeutic area
- Purpura, Thrombocytopenic, Idiopathic
- CHMP opinion
- Thu 16 Oct 2025
- EU approval
- Mon 22 Dec 2025
- Designations
- Orphan, Additional monitoring
- Application
- EMEA/H/C/006425
- ATC
- Not yet assigned
- Official record
- www.ema.europa.eu
Indication
Wayrilz is indicated for the treatment of immune thrombocytopenia (ITP) in adult patients who are refractory to other treatments (see section 5.1)
Regulatory milestones
Mon 22 Dec 2025🇪🇺 EU approval (EC decision)
Wayrilz (rilzabrutinib) approved in the EU
Marketing authorisation to Sanofi B.V.; Orphan, Additional monitoring · source
Thu 16 Oct 2025🇪🇺 CHMP positive opinion
Wayrilz (rilzabrutinib): CHMP positive opinion
Sanofi B.V.; Orphan, Additional monitoring · source
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.