FDA approves L-glutamine oral powder for compressing complications
WASHINGTON — The FDA affirmed Friday it has approved a new treatment for perseverants with sickle apartment malady: L-glutamine striking powder (Endari), listed for reducing unsparing complications associated with the likely.
“Endari is the start with treatment approved for patients with sickle cubicle affliction in scarcely 20 years,” Richard Pazdur, MD, fake the man of the Office of Hematology and Oncology End results in the FDA’s Center for Pick-me-up Evaluation and Take apart, said in a accusation.
The drug, put oned by Emmaus Medical, was put oned in placebo-controlled clinical asses to belittle both at all at any rates of hospital hold ins and admissions for vault sickle conk out crisis as fully as the prevalence of perceptive casket syndrome.
An FDA admonition cabinet had propounded permission for Emmaus’s L-glutamine in May.
L-glutamine is a below for nicotinamide adenine dinucleotide, which is depleted in sickle cubicle condition best to harmed endogenous antioxidant starch. According to Emmaus’s donation at the May advisory panel congress, “L-glutamine-induced luxuriates in redox insinuated may reduce oxidative tumefaction in [sickled] cubicles, resulting in waned RBC adhesion, ebbed vaso-occlusion, and in the future, fewer swelling sickle space crises.”