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Sarepta Will Challenge Expected No From EMA On Exondys 51

Executive Summary

Sarepta is expecting the European Medicines Agency to recommend against EU approval of its Duchenne muscular dystrophy treatment eteplirsen. Persuading the agency to change its mind during the appeal will be an uphill task for the company.

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Not The End For Exondys In EU, Says Sarepta

Sarepta Therapeutics’ hopes of marketing its controversial Duchenne muscular dystrophy drug in the EU have again been dashed, but the company says it hopes to learn from EU regulators next year what it can do to get the drug to patients in Europe. Meanwhile, sales of the product are going well in the US.

CHMP Preview: Lilly, Merck and Bayer Hopeful On Approvals; Sarepta’s Exondys Appeal Result Due

The European Medicines Agency’s key scientific committee, the CHMP, is deciding whether a raft of new products, including Eli Lilly’s galcanezumab, should be approved for sale across the EU. Sarepta’s appeal of the CHMP’s earlier rejection of its marketing application for Exondys is also slated for a decision.

CHMP Preview: Lilly, Merck and Bayer Hopeful On Approvals; Sarepta’s Exondys Appeal Result Due

The European Medicines Agency’s key scientific committee, the CHMP, is deciding whether a raft of new products, including Eli Lilly’s galcanezumab, should be approved for sale across the EU. Sarepta’s appeal of the CHMP’s earlier rejection of its marketing application for Exondys is also slated for a decision.

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