New treatment for sickle cell disease developed by Emmaus Medical receives positive opinion from EMA

Emmaus Medical, Inc., a pharmaceutical company developing a new treatment for sickle cell disease, and subsidiary of Emmaus Life Sciences, Inc., announced today that its investigational L-glutamine treatment for sickle cell disease has received a positive opinion recommending orphan medicinal product designation by the European Medicines Agency’s (EMA) Committee for Orphan Medicinal Products (COMP).

The designation allows Emmaus ten years of marketing exclusivity in EU member countries after the product obtains marketing authorization, as well as streamlined regulatory review processes and registration and other fee reductions.

“We are very pleased with the EMA’s recognition of our L-glutamine therapy as an orphan medicinal product for the treatment of sickle cell disease in Europe,” said Yutaka Niihara, M.D., MPH, founder and CEO of Emmaus. “This designation is an important milestone in our effort to make this treatment available to millions of patients around the world who currently have very few therapies available to them.”

Emmaus Medical has already received orphan drug and fast track designations from the U.S. Food and Drug Administration (FDA) for its patented L-glutamine drug, and is seeking FDA approval for L-glutamine as a treatment of sickle cell disease.  The drug was originally developed by investigators led by Dr. Niihara at the Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center and is now being tested in a Phase III clinical trial at sickle cell research centers in the United States. 

“Receiving orphan drug status in two major global regions will allow Emmaus Medical to continue its effort to provide L-glutamine treatment to sickle cell patients who currently have few options for treating this devastating disease,” said Dr. Henry McKinnell, Chairman of the Board of Emmaus Life Sciences, Inc. and former CEO of Pfizer, Inc.

For more information: www.emmausmedical.com