EU Approval Set For Three New Orphans And Lilly’s Emgality; Exondys Appeal Fails
The CHMP has upheld its previous negative opinion on Sarepta’s DMD treatment Exondys, but has given a raft of positive opinions on other novel products, including Lilly’s new migraine prophylactic Emgality, Spark Therapeutics’ gene therapy Luxturna for retinal dystrophy, and Vabomere, The Medicines Co/Rempex Pharmaceuticals’ new antibiotic for severe infections.
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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.
Merck & Co Needs To Go Low On Price For New HIV Drugs In EU
Pifeltro and Delstrigo have been backed for approval by the CHMP but how well they will fare on the market depends on a competitive pricing strategy and continuing to benefit from current European guidelines which recommend NNRTI-containing regimens for HIV.