Joenja (leniolisib)
OrphanExceptional circumstancesAdditional monitoring
- Region
- 🇪🇺 EU
- Active substance
- leniolisib
- Company
- Pharming Technologies B.V.
- Status
- Authorised
- Therapeutic area
- Primary Immunodeficiency Diseases
- CHMP opinion
- Thu 26 Mar 2026
- EU approval
- Thu 21 May 2026
- Designations
- Orphan, Exceptional circumstances, Additional monitoring
- Application
- EMEA/H/C/005927
- ATC
- L03AX22
- Official record
- www.ema.europa.eu
Indication
Joenja is indicated for the treatment of activated phosphoinositide 3-kinase delta syndrome (APDS) in adults and adolescents 12 years of age and older and weighing 45 kg or more.
Regulatory milestones
Thu 21 May 2026🇪🇺 EU approval (EC decision)
Joenja (leniolisib) approved in the EU
Marketing authorisation to Pharming Technologies B.V.; Orphan, Exceptional circumstances, Additional monitoring · source
Thu 26 Mar 2026🇪🇺 CHMP positive opinion
Joenja (leniolisib): CHMP positive opinion
Pharming Technologies B.V.; Orphan, Exceptional circumstances, 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.