BioCentury
ARTICLE | Company News

FDA panel to review Emmaus' sickle cell therapy

April 18, 2017 11:19 PM UTC

Emmaus Life Sciences Inc. (Torrance, Calif.) said FDA's Oncologic Drugs Advisory Committee intends to meet May 24 to discuss an NDA for Endari to treat sickle cell disease. Its PDUFA date is July 7.

The orally administered pharmaceutical grade L-glutamine candidate has Orphan Drug and Fast Track designation in the U.S., and Orphan Drug designation in the EU. In 2014, Emmaus said the candidate met the primary endpoint of reducing median frequency of sickle cell crises in a Phase III trial (see BioCentury Extra, March 19, 2014)...

BCIQ Company Profiles

Emmaus Life Sciences Inc.