Moment Of Truth For Eight New Drugs In EU
Mix Of Novel Treatments And Generics May Get Approval Recommendation
PTC Therapeutics’ gene therapy, eladocagene exuparvovec, and Sanofi’s enzyme replacement therapy, olipudase alfa, are among the latest products that the European Medicines Agency is considering for potential marketing approval.
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Amryt’s epidermolysis bullosa gel and Roche’s CD20xCD3 bispecific antibody for follicular lymphoma are among four drugs that have received the thumbs up from the European Medicines Agency.
The latest batch of new drug approvals in Japan includes several products receiving their first marketing clearances globally, notably a new oral competitor to a blockbuster ulcerative colitis drug and a high-need therapy for the rare disease ASMD.
Amryt Pharmaceuticals is set to appear before the European Medicines Agency to explain why its treatment for patients with epidermolysis bullosa merits EU-wide approval. The drug was recently rejected in the US.