Shots:
- The European Medicines Agency (EMA) advanced multiple marketing authorizations and positive opinions in May 2026 across pulmonology, oncology, rare diseases, immunology, aesthetics, and endocrinology, involving companies including Boehringer Ingelheim, Novartis, AstraZeneca, AbbVie, Pharming, and Amgen.
- CHMP positive opinions included Jascayd for idiopathic pulmonary fibrosis and progressive pulmonary fibrosis, Vijoice for PIK3CA-related overgrowth spectrum (PROS) disorders, Camizestrant (Etcamah) for ESR1-mutated advanced breast cancer, and Boey for the temporary improvement of glabellar lines in adults.
- The European Commission also approved Joenja for activated phosphoinositide 3-kinase delta syndrome (APDS) and Imdylltra for extensive-stage small cell lung cancer (ES-SCLC), expanding treatment options for patients with rare immunological disorders and difficult-to-treat cancers.
Company: Boehringer Ingelheim
Product: Jascayd
Active Ingredient: Nerandomilast
Disease: Idiopathic Pulmonary Fibrosis and Progressive Pulmonary Fibrosis
Date: May 21, 2026
Shots:
- The CHMP has recommended Jascayd (nerandomilast) for the treatment of adults with IPF and PPF
- Opinion was supported by the P-III (FIBRONEER-IPF and FIBRONEER-ILD) trials; both trials met their 1EPs, showing nerandomilast slowed lung function decline vs PBO through Wk-52. Nerandomilast also demonstrated a favorable safety/tolerability profile, with no liver monitoring requirement and PBO-like discontinuation rates as monotx.
- Jascayd (PO, BID) is a PDE4B inhibitor with antifibrotic and immunomodulatory effects, approved in the US, China, the UAE, and Japan for adults with IPF and PPF. Regulatory reviews are ongoing in the UK and other markets, with further approvals expected in 2026. Boehringer is also evaluating nerandomilast in SSc and IIM
Company: Novartis
Product: Vijoice
Active Ingredient: Alpelisib
Disease: PIK3CA-related overgrowth spectrum Disorders
Date: May 21, 2026
Shots:
- The CHMP has recommended Vijoice (alpelisib) for pts (age≥2 yrs) with severe or life-threatening PIK3CA-related overgrowth spectrum (PROS) disorders who require systemic therapy
- EMA’s recommendation is supported by a retrospective study of 57 PROS pts (age≥2 yrs) treated with alpelisib through a compassionate use program. Pts achieving at least a 20% reduction in the size of 1–3 abnormal growths or tumours after 24 wks, based primarily on imaging scans. At 24 wks, 37.5% of pts (12 of 32) responded to Vijoice treatment
- Vijoice will be available as 50 mg, 125 mg, and 200 mg film-coated tablets, and 50 mg granules. Alpelisib, is a PI3K inhibitor that reduces abnormal tissue growth by blocking PI3K enzyme activity
Company: AstraZeneca
Product: Etcamah
Active Ingredient: Camizestrant
Disease: Advanced Breast Cancer
Date: May 21, 2026
Shots:
- The CHMP has recommended Camizestrant + a CDK4/6 inhibitor (palbociclib, ribociclib or abemaciclib) for adults with ER+, HER2- locally advanced or metastatic breast cancer with an ESR1 mutation & no progression on 1L endocrine therapy + CDK4/6 inhibitor; regulatory review is ongoing in the US & Japan
- Opinion was based on the P-III (SERENA-6) trial assessing camizestrant + CDK4/6 inhibitor vs AI (anastrozole/letrozole) + CDK4/6 inhibitor in 315 pts with locally advanced or metastatic HR+/HER2- breast cancer harboring ESR1 mutation
- Trial showed a 56% reduction in the risk of disease progression or death (mPFS: 16 vs 9.2mos.), plus showed benefit in the time to second disease progression (25.7 vs 19.1mos.) & a favorable OS trend, which is under assessment. Data were published in The NEJM
Company: Allergan Aesthetics (AbbVie)
Product: Boey
Active Ingredient: TrenibotulinumtoxinE
Disease: Temporarily Improve Glabellar Lines in Adults
Date: May 21, 2026
Shots:
- The CHMP has recommended Boey (trenibotulinumtoxinE) to temporarily improve appearance of mod. to sev. glabellar lines in adults; decision is expected in the coming mos., & would be apply across all 30 EEA states
- Opinion was supported by data from 2 P-III trials assessing the efficacy & safety of Boey in adults with mod. to sev. glabellar lines (M21-500 & M21-508)
- The trials met all their 1 & 2EPs, showing rapid onset of action as early as 8hrs. after administration (the earliest assessment time) & observed efficacy duration for 2-3wks.
Company: Pharming
Product: Joenja
Active Ingredient: Leniolisib
Disease: Activated Phosphoinositide 3-Kinase Delta Syndrome
Date: May 21, 2026
Shots:
- The EC has approved Joenja for pts (≥12yrs.) with APDS syndrome across all 30 EEA states. Initial launch is expected in Germany in Q3’26, with further launches anticipated subject to completion of national reimbursement negotiations
- Approval was based on P-II/III trial of Joenja vs PBO in 31 APDS pts (≥12yrs.), showing significant improvement in immune dysregulation & immunodeficiency, plus was also supported by long-term OLE data in 37 pts treated with Joenja for a median of 3yrs.
- Joenja (PO), a PI3Kẟ inhibitor, is under regulatory review in Canada & other countries for APDS treatment & is also being investigated in 2 P-II trials for primary immunodeficiencies with immune dysregulation
Company: Amgen
Product: Imdylltra
Active Ingredient: Tarlatamab
Disease: ES-SCLC
Date: May 29, 2026
Shots:
- The EC has approved Imdylltra (tarlatamab) as a monotx. to treat adults with extensive-stage small cell lung cancer (ES-SCLC) who require systemic therapy following disease progression on or after 1L treatment with Pt-based CT
- Approval was based on the P-III (DeLLphi-304) trial assessing Imdelltra vs SoC CT (topotecan globally excl. Japan; lurbinectedin in the US, Canada, Australia, Singapore, Korea; amrubicin in Japan) in SCLC pts (n=509) who progressed on or after 1L of Pt-based CT
- Trial showed that Imdylltra reduced the risk of death by 40%, with mOS of 13.6 vs 8.3mos. in ES-SCLC pts who progressed on or after 1L of Pt-based CT; data was published in The NEJM
Note:
- The following drugs have been approved; however, no PR was available:
- Bopediat (furosemide)
- Adstiladrin (nadofaragene firadenovec)
Related Post: EMA Marketing Authorization of New Drugs in April 2026
