EMA Marketing Authorization of New Drugs in June 2026    

Shots:  The European Medicines Agency (EMA) advanced multiple marketing authorizations and positive opinions in June 2026 across oncology, neurology, rare diseases, metabolic disorders, and infectious diseases, involving companies including Amgen, Immedica, Sanofi, Arrowhead Pharmaceuticals, Acadia Pharmaceuticals, and Zambon.  European Commission approvals included Imdylltra for extensive-stage small cell lung cancer (ES-SCLC), Zepzelca + Tecentriq as a first-line maintenance therapy for ES-SCLC, Cenrifki for secondary progressive multiple sclerosis (SPMS) without relapses, and Redemplo for familial chylomicronemia syndrome (FCS).  CHMP positive opinions were granted for Daybu to treat neurobehavioral symptoms of Rett syndrome and Hopledo for Parkinson’s disease with moderate to severe motor fluctuations. Additionally, CHMP issued positive opinions for Onswik (insulin efsitora alfa) and Aujemflu (influenza vaccine), while the European Commission also approved Adstiladrin and Bopediat, further expanding treatment options across oncology, neurology, endocrinology, and infectious diseases.  Amgen Reports the EC Approval of Imdylltra to Treat ES-SCLC                 Company: Amgen                 Product: Imdylltra                   Active Ingredient: Tarlatamab                 Disease: ES-SCLC                 Date: Jun 01, 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  Immedica Receives EC Approval for Zepzelca + Tecentriq to Treat 1L ES-SCLC                 Company: Immedica                    Product: Zepzelca + Tecentriq                 Active Ingredient: Lurbinectedin + Atezolizumab                 Disease: ES-SCLC                   Date: Jun 01, 2026                  Shots:  The EC has approved Zepzelca (Lurbinectedin) + Tecentriq (Atezolizumab) as a 1L therapy for adults with ES-SCLC whose disease remains stable after initial treatment with Tecentriq, carboplatin, & etoposide  Approval was based on P-III (IMforte) trial results, showing Zepzelca + Tecentriq reduced the risk of progression or death by 46% & death risk by 27% vs Tecentriq alone. Trial showed mOS of 13.2 vs 10.6mos. & mPFS of 5.4 vs 2.1 mos. for Zepzelca + Tecentriq vs Tecentriq alone, following four induction therapy cycles from randomization; data were presented at ASCO’25 & published in The Lancet  Immedica holds Zepzelca distribution rights through its strategic partnership with PharmaMar across the Nordics, UK & Ireland, Central and Eastern Europe, the Middle East, and North Africa  Sanofi Reports the EC Approval for Cenrifki (Tolebrutinib) to Treat SPMS without Relapses                 Company: Sanofi                 Product: Cenrifki                 Active Ingredient: Tolebrutinib                 Disease: SPMS without Relapses                 Date: Jun 22, 2026                  Shots:  The EC has approved Cenrifki (PO, QD) for the treatment of secondary progressive multiple sclerosis (SPMS) without relapses in the last 2yrs.  Approval was backed by P-III (HERCULES) trial (vs PBO) in non-relapsing SPMS (nrSPMS) & supporting data from P-III (GEMINI 1 & 2) studies (vs teriflunomide) in relapsing MS, with HERCULES demonstrating delayed onset of disability progression  Cenrifki is an oral, brain-penetrant BTK inhibitor, which will be commercially available in Germany in 2026, supported by the required Risk Management Program and robust Patient Support Program  Arrowhead Pharmaceuticals Receives the EC Approval for Redemplo to Treat Familial Chylomicronemia Syndrome                 Company: Arrowhead Pharmaceuticals                 Product: Redemplo                   Active Ingredient: Plozasiran                 Disease: Familial Chylomicronemia Syndrome                 Date: Jun 22, 2026                  Shots:  The EC has approved Redemplo as an adjunct to diet to reduce triglycerides (TGs) in adults with Familial Chylomicronemia Syndrome (FCS), backed by the P-III (PALISADE) trial assessing it (25 & 50mg, SC, Q3M) vs PBO in 75 FCS adults  Trial met its 1 & all multiplicity-controlled key 2EPs. 25mg showed an 80% vs 17% median TG reduction, while pooled plozasiran groups demonstrated 83% lower odds of acute pancreatitis  Redemplo is also being investigated in the P-III trial for adults with severe hypertriglyceridemia: SHASTA-3, SHASTA-4, & SHASTA-5, and P-III (MUIR-3) trial for adults with hypertriglyceridemia  Acadia Pharmaceuticals’ Daybu (Trofinetide) Receives the CHMP Positive Opinion for Rett Syndrome                 Company: Acadia Pharmaceuticals                 Product: Daybu                   Active Ingredient: Trofinetide                 Disease: Rett Syndrome                 Date: Jun 25, 2026                  Shots:  The CHMP has recommended Daybu (trofinetide) for the treatment of neurobehavioral symptoms of Rett syndrome in pts (≥5yrs.); If approved, authorization would be valid in all 30 EEA states  Opinion was based on the results from the P-III (LAVENDER) study, which showed improvements in core features of Rett syndrome, as measured by RSBQ & CGI-I scale  Daybu is a synthetic analog of the N-terminal tripeptide of insulin-like growth factor 1  Zambon’s Hopledo Receives the CHMP Positive Opinion for Parkinson’s Disease and Moderate to Severe Motor Fluctuations                 Company: Zambon                 Product: Hopledo                 Active Ingredient: Levodopa / Carbidopa                 Disease: Parkinson’s Disease and Moderate to Severe Motor Fluctuations                 Date: Jun 25, 2026                  Shots:  The CHMP has recommended Hopledo for the treatment of adults with Parkinson’s disease & mod. to sev. motor fluctuations who have not been sufficiently stabilized with oral levodopa/DDC inhibitor-based treatments  Opinion was based on the P-III (RISE-PD) trial assessing Hopledo in pts with Parkinson’s disease & mod. to sev. motor fluctuations, which showed a significant increase in Good ON time over immediate-release LD/CD with fewer daily doses  Hopledo is an oral, modified-release formulation of levodopa/carbidopa designed for the treatment of fluctuations of Parkinson’s disease, with a phased EU launch planned from Oct 2026 following approval  Note:   The following drugs have been granted CHMP; however, no PR was available:         Onswik (Insulin efsitora alfa)  Aujemflu (Influenza vaccine)  The following drugs have been approved; however, no PR was available:          Adstiladrin (nadofaragene firadenovec)  Bopediat (Furosemide)  The post EMA Marketing Authorization of New Drugs in June 2026     appeared first on PharmaShots.