Emmaus: ‘We Might Stand A Better Chance In Europe Without The EMA’
The company will need new data if it uses the decentralized route For Xyndari
Emmaus Life Sciences is dusting itself off following the rejection by the European Medicines Agency of the company’s sickle cell disease drug, Xyndari. The company tells the Pink Sheet that it might have better luck in Europe on a country-by-country basis in member states where experts have shown support for its product and where there are many patients with the condition. Not surprisingly, the EMA has defended the system it follows.
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Three new drugs for sickle cell disease could be on the market in the US next year, representing a groundswell of advancement for the devastating blood disorder that has had limited options.
Seven new products, including the world’s first ever Ebola vaccine, are on track to receive EU-wide approval. Meanwhile, two drugs have failed to make the grade.
Seven new drugs have this week moved closer to gaining EU approval following positive recommendations from the European Medicines Agency, but Emmaus’ glutamine product has fared less well and the company is considering another route for getting the drug to sickle cell disease patients in Europe