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by myTomorrows myTomorrows

New England Journal of Medicine publishes Phase 3 clinical trial data of Pharmaceutical Grade L-glutamine for the treatment of Sickle Cell Disease

Peer-reviewed publication provides additional insights into Emmaus Life Sciences Inc.’s FDA approved Sickle Cell Disease treatment.

myTomorrows announces that phase 3 clinical data of Pharmaceutical Grade L-glutamine (L-glutamine) for the treatment of Sickle Cell Disease has been published by the prestigious New England Journal of Medicine. The treatment, developed by Emmaus Life Sciences Inc., has met both primary and secondary endpoints in the most recent phase 3 study.

 

“Among children and adults with sickle cell anemia, the median number of pain crises over 48 weeks was lower among those who received oral therapy with l-glutamine, administered alone or with hydroxyurea, than among those who received placebo, with or without hydroxyurea”

-- Niihara Y, Miller S, Kanter J, et al. A Phase 3 Trial of L-Glutamine in Sickle Cell, New Eng. J. Med. 2018; 379(3):226–235

 

L-glutamine received FDA approval on 7 July 2017 for the treatment of Sickle Cell Disease in adult and paediatric patients 5 years of age and older. In Europe, the Marketing Authorization Application for L-glutamine is currently under assessment by the EMA for the treatment of Sickle Cell Disease. During this process, the treatment is available through a named-patient Early Access Program, managed by myTomorrows.

 

About myTomorrows

At myTomorrows, we believe that everyone should be able to access all suitable treatment options, whenever available, wherever they exist. Working together with medicine manufacturers to devise and execute strategies for early access, we strive to make it easier for doctors and their patients who ran out of viable treatment options to find, get information about and access to medicines in development. myTomorrows has developed a Knowledge Base to combine vast amounts of medical and clinical data to present an actionable overview of the full clinical development pipeline.

 

About Sickle Cell Disease

Sickle Cell Disease is a hereditary blood disorder leading to debilitating episodes of crises and pain, potentially causing organ damage, strokes and a variety of other severe side effects. Sickle Cell Disease affects approximately 80.000 patients in Europe and millions worldwide, but it is considered a rare disease

 

For more information, please contact medical@mytomorrows.com (+31 88 525 38 13)