Why 2025 Could See A Surge In EMA Approval Opinions For ATMPs

Seven ATMPs Could Be Backed For Pan-EU Approval In 2025

Marketing authorization applications for five new advanced therapy medicinal products were filed with the European Medicines Agency in 2024, the highest number in any year since 2020. The Pink Sheet looks at these and two other ATMPs that might get the thumbs up from the European Medicines Agency in 2025.

Pgenetherapy filings
(Shutterstock)

Seven new advanced therapy medicinal products (ATMPs) could be approved for pan-EU approval this year, based on data from the Pink Sheet’s EU regulatory filings tracker, including Roche/Sarepta Therapeutics’ Duchenne gene therapy delandistrogene moxeparvovec, known as Elevidys in the US and several other nations where it is already approved.

During 2024, five companies filed EU marketing authorization applications (MAAs) for ATMPs, up from four in 2023, one in 2022 and three in 2021. The number of filings in 2024 is the highest since 2020, when nine ATMPs were filed

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