Shots:
- Innovation in drug development continues to reshape patient care across dermatology, cardiology, immunology, oncology, respiratory medicine, and infectious diseases, as regulatory momentum in Europe remains strong toward the end of 2025. Recent EMA actions highlight how advanced biologics, precision small molecules, and next-generation vaccines are translating clinical breakthroughs into real-world impact.
- In December 2025, the EMA issued multiple positive CHMP opinions and EC approvals spanning a broad therapeutic spectrum. These included GSK’s Exdensur (depemokimab) for type 2 inflammatory asthma and CRSwNP; Moderna’s mNEXSPIKE (mRNA-1283) COVID-19 vaccine; ImmunityBio’s Anktiva, which received conditional EU approval in combination with BCG for BCG-unresponsive non-muscle invasive bladder cancer; and Sanofi’s Wayrilz (rilzabrutinib) for adults with refractory immune thrombocytopenia.
- In December 2025, the EMA authorised seven new therapies in the EU, matching the seven approvals issued by the US FDA during the same month. This alignment highlights continued global momentum and regulatory convergence in advancing innovative and cutting-edge treatments, reinforcing the shared commitment to improving patient access to new medicines worldwide.
Company: Cosmo Pharmaceuticals and Glenmark Pharmaceuticals
Product: Winlevi
Active Ingredient: Clascoterone
Disease: Acne
Date: Dec 01, 2025
Shots:
- The EC has approved Cosmo Pharmaceuticals and Glenmark Pharmaceuticals’ Winlevi (clascoterone 10 mg/g cream) for the Treatment of Acne Vulgaris in 17 countries in Europe
- Winlevi is authorized in the EU for treating acne vulgaris in adults and adolescents aged 12 to <18 years, with adolescent use limited to facial application
- Following approval, Glenmark will begin commercializing Winlevi across 17 European countries, including Belgium, France, Spain, the Netherlands, and Sweden, among others
Company: Cytokinetics
Product: Myqorzo
Active Ingredient: Aficamten
Disease: Obstructive Hypertrophic Cardiomyopathy
Date: Dec 11, 2025
Shots:
- The CHMP has recommended Cytokinetics’ Myqorzo for the treatment of adults with symptomatic (NYHA, class II-III) oHCM, with EC decision expected in Q1’26
- Opinion was based on P-III (SEQUOIA-HCM) trial of Myqorzo, showing improved exercise capacity vs PBO at 24wks., with increased peak oxygen uptake by 1.8 vs 0 ml/kg/min, consistent across all subgroups & in pts with or without background beta-blocker therapy. Results were published in The NEJM
- Additionally, Myqorzo is under regulatory review in other countries, incl. the US (PDUFA: Dec 26, 2025), while China’s NMPA is reviewing its NDA under Priority Review
Company: GSK
Product: Exdensur
Active Ingredient: Depemokimab
Disease: Asthma with Type 2 Inflammation and CRSwNP
Date: Dec 11, 2025
Shots:
- CHMP recommended depemokimab as add-on maintenance therapy for asthma pts (≥12yrs.) with type 2 inflammation (eosinophilic) & as add-on therapy for inadequately controlled CRSwNP, based on P-III (SWIFT & ANCHOR) trials, respectively; EC’s decision expected in Q1’26
- SWIFT-1 (n=382) & SWIFT-2 (n=380) trials showed depemokimab reduced asthma exacerbations by 54% over 52wks. (1EP) & hospitalization-requiring events by 72% (2EP) vs PBO + SoC. The AGILE OLE study confirmed sustained safety & efficacy with Q6W dosing over 2yrs.
- ANCHOR-1 (n=271) & ANCHOR-2 (n=257) trials assessed depemokimab vs PBO in CRSwNP pts on intranasal corticosteroids, which showed reduced nasal polyp size at 52wks. & improved nasal obstruction verbal response over Wks. 49-52
Company: ImmunityBio
Product: Anktiva
Active Ingredient: Nogapendekin Alfa Inbakicept
Disease: Obstructive Hypertrophic Cardiomyopathy
Date: Dec 11, 2025
Shots:
- The EMA has recommended conditional EU marketing authorization for Anktiva (nogapendekin alfa inbakicept) plus Bacillus Calmette-Guérin (BCG) to treat BCG-unresponsive NMIBC carcinoma in situ.
- Recommendation was based on safety and efficacy data in 100 adults, showing a 71% CR rate, with responses lasting a median of ~27 mos and extending up to 54+ mos; CR rates among responders were 66% at 12 mos and 42% at 24 mos. ImmunityBio will continue post-marketing follow-up to submit long-term safety and efficacy data to the EMA.
- ANKTIVA is an IL-15 receptor agonist indicated with BCG for adults with BCG-unresponsive NMIBC CIS, with or without papillary tumors
Company: Moderna
Product: mNEXSPIKE
Active Ingredient: COVID-19 mRNA Vaccine
Disease: COVID-19
Date: Dec 11, 2025
Shots:
- The CHMP has recommended mNEXSPIKE (mRNA-1283), a COVID-19 vaccine, for active immunization against SARS-CoV-2 in individuals (age≥12 yrs)
- Opinion was based on the P-III trial evaluating mNEXSPIKE (mRNA-1283; 10 µg) versus Spikevax (mRNA-1273; 50 µg) in ~11,400 participants (age ≥12 yrs), with primary efficacy assessed from 14 days post-vaccination
- The trial met its 1EP with mNEXSPIKE showing 9.3% superior relative vaccine efficacy (rVE) in subjects (≥12yrs.), whereas in a descriptive sub-group analysis mNEXSPIKE showed 13.5% higher rVE in participants (≥65yrs.). mRNA-1283 demonstrated a safety profile comparable to mRNA-1273
Company: Sanofi
Product: Wayrilz
Active Ingredient: Rilzabrutinib
Disease: Immune Thrombocytopenia
Date: Dec 22, 2025
Shots:
- The EC has approved Wayrilz for adults with Immune Thrombocytopenia (ITP) who are refractory to other treatments
- Approval was based on P-III (LUNA 3) trial assessing Wayrilz (400mg, BID, PO) vs PBO in adults (n=202) with ITP over 12wks., after which 64% vs 32% achieving durable platelet count continued for 24wks., followed by 28wk. OLE & 4wk. safety follow-up; study is ongoing in adolescents
- Trial met its 1 & 2EPs, showing sustained platelet response at 25wks. (23% vs 0%), faster onset (36 days vs not reached), & longer duration (7 vs 0.7wks.). Pts also achieved a 10.6-point QoL improvement vs 2.3 per ITP Patient Assessment Questionnaire; data was presented at ASH’24 & published in The Blood
Note: The following drug has been granted CHMP; however, no PR was available:
- Aumseqa (Aumolertinib)
Related Post: Insights+: EMA Marketing Authorization of New Drugs in November 2025
