Posted by Michael Wonder on 01 Dec 2016
Emmaus Life Sciences receives notice of FDA PDUFA date for investigational L-glutamine treatment for sickle cell disease
29 November 2016 - Emmaus Life Sciences announced today that the U.S. FDA has set a PDUFA date of 7 July 2017 for a decision on the Company’s new drug application for its orally-administered pharmaceutical grade L-glutamine (PGLG) product for the treatment for sickle cell disease.
The company also announced it will present data from a subgroup analysis of its Phase 3 clinical trial with PGLG treatment at the 58th American Society of Hematology Annual Meeting & Exposition in San Diego, CA.
