Emmaus Life Sciences Inc. (Emmaus) has announced that EndariTM for the treatment of sickle cell disease (SCD) has been recommended for approval by the Food and Drug Administration (FDA)’s Oncologic Drugs Advisory Committee. In a10–3 vote, the committee recognized that the overall benefit-risk profile of disease was favorable. MMS Holdings Inc. (MMS) has been providing clinical data, writing and regulatory submission support for Emmaus since 2015.
“MMS is so pleased to hear the outcome of the May 24th Advisory Committee meeting where the committee recommended the approval of Endari™, Emmaus’ treatment of SCD,” commented Uma Sharma, PhD, Chief Scientific Officer at MMS.
Dr. Sharma added, “We have been working with Emmaus for several years and it is clear the company brings a passion to this research. We are equally excited that we may soon see a new treatment for those with sickle cell disease and the first of its kind for pediatric patients. MMS looks forward to continuing to support Emmaus and the FDA through this review period.”
About MMS Holdings Inc. MMS is a global clinical research organization that supports the pharmaceutical and biotech industries with a proven, scientific approach to complex regulatory submission challenges. Our strong industry experience and data-driven approach to drug development makes us a valuable partner in creating compelling submissions that meet rigorous regulatory standards.
About Emmaus Life Sciences Emmaus Life Sciences is engaged in the discovery, development and commercialization of innovative treatments and therapies for rare diseases. The company’s research on sickle cell disease was initiated by Yutaka Niihara, MD, MPH, Chairman and CEO of Emmaus, at the Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center. For more information, please visit www.emmauslifesciences.com.