Emmaus Fumes After EMA Rejects Sickle Cell Drug Again

The US firm has withdrawn its submission to get EU approval for Xyndari. After being turned down by the CHMP, Emmaus may try the decentralized approval procedure instead.

Tearing
Rip it up and start again: Emmaus looks at new option to get Xyndari approved • Source: Shutterstock

Emmaus Life Sciences Inc. has ripped up its European filing of Xyndari, which is approved in the US, after the continent's regulators once again recommended against approving the sickle cell drug.

The US firm, which was delisted from the NASDAQ last week, has announced the withdrawal of its marketing authorization application to the European Medicines Agency for Xyndari, a prescription grade version of the amino acid supplement L-glutamine, for the treatment of sickle cell disease

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