Shots:
- The European Medicines Agency advanced multiple approvals and late-stage recommendations in April 2026 across infectious diseases, neurology, immunology, endocrinology, and rare disorders, involving companies including Merck, Moderna, Novartis, Sanofi, and Mitsubishi Tanabe Pharma
- CHMP positive opinions included Redemplo for familial chylomicronemia syndrome, Itvisma for spinal muscular atrophy, and Cenrifki for non-relapsing SPMS
- The EC also approved therapies including Enflonsia for RSV prevention in infants, mCOMBRIAX for influenza/COVID-19 prevention, Palsonify for acromegaly, Rhapsido for chronic spontaneous urticaria, Xolremdi for WHIM syndrome, and Onerji for Parkinson’s disease
Company: Merck
Product: Enflonsia
Active Ingredient: Clesrovimab
Disease: RSV Prevention in Infants
Date: Apr 15, 2026
Shots:
- The EC has approved Enflonsia (clesrovimab) to prevent RSV lower respiratory tract disease in newborns & infants entering their first RSV season based on P-IIb/III (CLEVER) study assessing Enflonsia in preterm & full-term infants (≤1yr.), plus P-III (SMART) study of Enflonsia vs palivizumab in high-risk infants
- The Phase 2b/3 CLEVER trial (N=3,614) evaluated in infants entering their first RSV season. ENFLONSIA reduced RSV-associated medically attended LRIs by 60.4% and hospitalizations by 84.2% vs PBO through 5 mos. It also reduced severe RSV MALRI by 91.7% and RSV-associated LRI hospitalizations by 90.9%, meeting 1EP and 2EPs. Data from the CLEVER and SMART trials were published in The NEJM in Sept. 2025
- Enflonsia (105mg/0.7 mL, PFS) is a long-acting preventive monoclonal antibody designed to deliver immediate & sustained protection for up to 5mos., with a single weight-independent dose
Company: Moderna
Product: mCOMBRIAX
Active Ingredient: Influenza and COVID 19, mRNA Vaccine
Disease: Influenza and COVID-19
Date: Apr 20, 2026
Shots:
- The EC has approved mCOMBRIAX (mRNA-1083), a combination vaccine for the prevention of influenza and COVID-19 in patients ≥50 yrs. across all 30 EEA states
- Approval was based on a P-III trial evaluating mRNA-1083 in ~8,000 adults across two cohorts: ≥65yrs (n~4,000) vs co-administered Fluzone / Efluelda (a high dose influenza vaccine )+ Spikevax and 50–64yrs (n~4,000) vs Fluarix + Spikevax, where all 1EPs were met, demonstrating non-inferiority of immune response with acceptable safety and tolerability
- MRNA-1010, Moderna’s investigational seasonal influenza vaccine is under regulatory review in the EU, US, Canada, and Australia
Company: Arrowhead Pharmaceuticals
Product: Redemplo
Active Ingredient: Plozasiran
Disease: Familial Chylomicronemia Syndrome
Date: Apr 23, 2026
Shots:
- The CHMP has recommended Redemplo as an adjunct to diet to reduce triglycerides (TGs) in adults with FCS; EC’s decision is expected in Q2’26
- Opinion was supported by the P-III (PALISADE) trial assessing Redemplo (25mg & 50mg, SC, Q3M) vs PBO in 75 adults with genetically confirmed/clinically diagnosed FCS. Pts could join a 2-part extension period where all receive Redemplo after completing randomization
- Trial met its 1 & all multiplicity-controlled key 2EPs, with reductions in TGs & apoC-III. Redemplo (25mg) showed an 80% median TG reduction vs 17% & demonstrated a lower numerical rate of acute pancreatitis; data was published in The NEJM & Circulation
Company: Novartis
Product: Itvisma
Active Ingredient: Onasemnogene abeparvovec
Disease: Spinal Muscular Atrophy
Date: Apr 23, 2026
Shots:
- The CHMP has recommended Itvisma (onasemnogene abeparvovec) for the treatment of pts (≥2yrs.) living with 5q spinal muscular atrophy (SMA) harboring a confirmed bi-allelic mutation in the SMN1 gene
- Opinion was based on the P-III (STEER) trial & P-IIIb (STRENGTH) study, where STEER showed a 2.39-point improvement in the HFMSE with effects sustained over 52wks. vs 0.51 in Sham. Both trials demonstrated benefit in treatment-naïve as well as experience pts
- Itvisma is a gene replacement therapy that delivers a functional SMN1 gene via a single intrathecal dose, enabling sustained SMN protein expression to improve motor function in SMA pts
Company: Sanofi
Product: Cenrifki
Active Ingredient: Tolebrutinib
Disease: Non-Relapsing SPMS
Date: Apr 23, 2026
Shots:
- The CHMP has recommended Cenrifki for the treatment of SPMS without relapses in the last 2yrs.; regulatory submissions are ongoing in other regions
- Opinion was backed by P-III (HERCULES) trial in non-relapsing SPMS & supporting data from P-III (GEMINI 1 & 2) studies in relapsing multiple sclerosis, with HERCULES demonstrating delayed onset of disability progression
- Cenrifki is an oral, brain-penetrant BTK inhibitor designed to target smoldering neuroinflammation for delaying disability progression in multiple sclerosis
Company: Crinetics Pharmaceuticals
Product: Palsonify
Active Ingredient: Paltusotine
Disease: Acromegaly
Date: Apr 23, 2026
Shots:
- The EC has approved Palsonify (paltusotine) for treating adults with acromegaly who are ineligible for or inadequately respond to surgery across all 30 EEA states
- EC approval was supported by P-III PATHFNDR-1 & PATHFNDR-2 trials evaluating Palsonify in previously treated & medically untreated adults with acromegaly, demonstrating rapid onset, reliable biochemical control & sustained efficacy; it also received ODD in EU
- Crinetics plans initial Palsonify commercialization in Germany & Austria, partnered with Sanwa Kagaku Kenkyusho for Japan, where paltusotine received orphan drug designation & an NDA was filed; an MAA was also submitted to Brazil’s ANVISA
Company: Novartis
Product: Rhapsido
Active Ingredient: Remibrutinib
Disease: Chronic Spontaneous Urticaria
Date: Apr 23, 2026
Shots:
- The EC has approved Rhapsido (Remibrutinib) for the treatment of adults with chronic spontaneous urticaria (CSU) who remain symptomatic despite H1 antihistamine treatment
- Approval was supported by P-III (REMIX-1 & 2) trials (n=925) in CSU pts, where remibrutinib showed superior improvements in itch, hives & weekly urticaria activity at Wk.12 vs PBO in pts uncontrolled on H1-antihistamines, with a favorable safety profile requiring no lab monitoring
- Rhapsido (PO, BID) blocks BTK to inhibit the release of histamine & other proinflammatory mediators for CSU treatment, plus it is being evaluated across multiple trials for CIndU, hidradenitis suppurativa, & food allergy
Company: X4 Pharmaceuticals
Product: Xolremdi
Active Ingredient: Mavorixafor
Disease: WHIM Syndrome
Date: Apr 27, 2026
Shots:
- The EC has approved Xolremdi (Mavorixafor), under exceptional circumstances, for the treatment of WHIM syndrome
- Approval was supported by the global pivotal P-III (4WHIM) trial, PBO-controlled 52-wk study evaluating mavorixafor’s efficacy & safety in pts ≥12 yrs with WHIM syndrome
- Xolremdi (PO, QD), a CXCR4 antagonist, is used in pts ≥12 yrs with WHIM syndrome to increase circulating mature neutrophils & lymphocytes
Company: Tanabe Pharma
Product: Onerji
Active Ingredient: Levodopa/Carbidopa
Disease: Parkinson’s Disease
Date: Apr 27, 2026
Shots:
- The EC has approved Onerji (levodopa/carbidopa) infusion for advanced PD pts with uncontrolled motor fluctuations. The therapy is being developed by its wholly owned subsidiary, NeuroDerm
- Approval was based on the global P-III (BouNDless) trial, which demonstrated Onerji + supplemental oral LD/CD significantly increased ON time without troublesome dyskinesia and reduced OFF time vs immediate-release oral LD/CD. Favourable long-term safety and tolerability results were also observed in the late P-II (BeyoND) study
- Onerji is a 24-hour continuous SC liquid LD/CD infusion therapy for advanced PD pts with motor fluctuations. Delivered via a portable infusion pump system, it is designed to maintain stable LD plasma concentrations and improve PK profiles
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