Research & Development
Emmaus wins Endari's orphan drug status in Switzerland
4 December 2020 -

Sickle cell disease treatment company Emmaus Life Sciences Inc (OTC:EMMA) reported on Thursday the receipt of the orphan drug status for Endari from Swiss Agency for Therapeutic Products (Swissmedic) for the treatment of patients with sickle cell disease.

Additionally, Endari has received the orphan drug status and orphan medicinal status in the US and the EU (Xyndari), respectively.

Concurrently, the company is preparing an Endari Marketing Authorization (MA) application for submission to Swissmedic. The MA review and approval process typically takes 16 to 18 months.

In conjunction, Endari will be available to sickle cell disease patients on an early access basis to address an unmet medical need in Switzerland during the review and approval process, according to the company.

Endari, the company's prescription grade L-glutamine oral powder, was approved by the FDA in 2017 for treating sickle cell disease in adult and pediatric patients five years of age and older. Sales of Endari began in the US in 2018. Endari received marketing authorization from the Israeli Ministry of Health in 2020 and is currently available to sickle cell disease patients on an early access basis in the EU and the ME.

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