TORRANCE, Calif. — VIEW E-MEDIA KIT – Emmaus Life Sciences, Inc. (Emmaus) arise today that the New England Journal of Medicine (NEJM) has arise the after-effects of its 48-week appearance 3 analytic balloon of Endari™ (L-glutamine articulate powder) which accurate the FDA approval in July 2017 to abate the astute complications of sickle corpuscle ache in developed and pediatric patients 5 years of age and older.
The commodity letters after-effects that showed decidedly beneath sickle corpuscle crises in those accepting Endari compared to placebo by 25 percent; p=0.005 (median 3 vs. average 4) and decidedly beneath hospitalizations by 33 percent; p=0.005 (median 2 vs. average 3). Additional allegation showed lower accumulative canicule in hospital of 41 percent; p=0.02 (median 6.5 canicule vs. average 11 days) and a lower accident of astute affection (ACS) by added than 60 percent; p=0.003 (13 of 152 patients [8.6%] had at atomic 1 ACS compared with 18 of 78 in the placebo accumulation [23.1%]). The best accepted adverse reactions, occurring in greater than 10 percent, of the analytic abstraction were constipation, nausea, headache, belly pain, cough, affliction in extremity, aback pain, and pain.
“Endari is the aboriginal accustomed analysis for sickle corpuscle ache in pediatric patients 5 years of age and earlier and the aboriginal in about 20 years for adults. Our achievement in administration the after-effects of this abstracts from the New England Journal of Medicine, a advertisement with accepted ability and significance, is to aid in accretion the acquaintance of sickle corpuscle disease, a constant ancestral claret ataxia which frequently affects those of African descent, as able-bodied as those from Central and South America and bodies of Middle Eastern, Asian, Indian and Mediterranean descent,” said co-author Yutaka Niihara, MD, CEO and architect of Emmaus.
“Sickle corpuscle ache affects bags of bodies in the United States,” said Beverley Francis-Gibson, President and CEO of The Sickle Corpuscle Ache Association of America, Inc. “While there is no accepted cure for this life-threatening disease, accommodating acquaintance and apprenticeship on analysis options abide important factors for the sickle corpuscle community.”
Additional Advice About the Appearance 3 Analytic StudyThe randomized, double-blind, placebo-controlled, multicenter Appearance 3 balloon evaluated the ability and assurance of Endari (0.3 gram per kilogram of anatomy weight per dose) administered alert circadian by mouth, as compared with placebo. The abstraction included patients at atomic 5 years of age with sickle corpuscle anemia or sickle β0-thalassemia, with a history of two or added affliction crises during the antecedent year. Patients who were accepting hydroxyurea at a dosage that had been abiding for at atomic 3 months afore screening and who connected such analysis during the 48-week analysis aeon were eligible. A absolute of 230 patients (age range, 5 to 58 years; 53.9% female) were about assigned, in a 2:1 ratio, to accept L-glutamine (152 patients) or placebo (78 patients).
About Sickle Corpuscle DiseaseSickle corpuscle ache is an affiliated claret ataxia characterized by the assembly of an adapted anatomy of claret which polymerizes and becomes fibrous, causing red claret beef to become adamant and change anatomy so they arise sickle shaped instead of bendable and rounded. Patients with sickle corpuscle ache ache from debilitating episodes of sickle corpuscle crises, which action aback the rigid, adhering and adamant red claret beef choke claret vessels. Sickle corpuscle crises account astute affliction as a aftereffect of bereft oxygen actuality delivered to tissue, referred to as tissue ischemia, and inflammation. These contest may advance to a array of added adverse outcomes such as astute affection that requires hospitalization. Sickle corpuscle ache is an drop disease, affecting about 100,000 patients in the U.S. and millions worldwide, with cogent unmet medical needs.
About EndariEndari (L-glutamine articulate powder) is a decree articulate analysis accustomed by the U.S. Food and Drug Administration (FDA) to abate the astute complications of sickle corpuscle ache in developed and pediatric patients 5 years of age and older. Endari was accustomed in July 2017 and was the aboriginal analysis in about 20 years apparent to abate the astute complications of sickle corpuscle ache in adults aback acclimated as directed. Endari is additionally the aboriginal analysis accustomed to abate the astute complications of sickle corpuscle ache in accouchement bristles years and earlier aback acclimated as directed. Endari has accustomed Drop Drug appellation in the U.S., and Drop Medicinal Artefact appellation in the EU.
Important Assurance InformationThe best accepted adverse reactions (incidence >10 percent) in analytic studies were constipation, nausea, headache, belly pain, cough, affliction in extremities, aback affliction and pain.
Adverse reactions arch to analysis cessation included one case anniversary of hypersplenism, belly pain, dyspepsia, afire awareness and hot flash.
The assurance and ability of Endari in pediatric patients with sickle corpuscle ache adolescent than bristles years of age has not been established.
For added information, amuse see abounding Prescribing Advice of Endari at: www.ENDARIrx.com/PI
About Emmaus Life Sciences, Inc.Emmaus Life Sciences, Inc. is a biopharmaceutical aggregation affianced in the discovery, development and commercialization of avant-garde treatments and therapies primarily for attenuate and drop disease. Its advance product, Endari, approved absolute analytic after-effects in the completed Appearance 3 analytic balloon for sickle corpuscle anemia and sickle ß0-thalassemia and has accustomed FDA approval. Visit: http://www.emmausmedical.com/.
Forward-Looking StatementsThis columnist absolution contains advanced statements as that appellation is authentic in the Private Securities Litigation Reform Act of 1995, apropos the research, development and abeyant commercialization of biologic products. Such advanced statements are based on accepted expectations and absorb inherent risks and uncertainties, including factors that could delay, alter or change any of them, and could account absolute outcomes and after-effects to alter materially from accepted expectations. Additional risks and uncertainties are declared in letters filed by Emmaus Life Sciences, Inc., with the U.S. Securities and Exchange Commission, including its Annual Report on Anatomy 10-K and Quarterly Letters on Anatomy 10-Q. Emmaus is accouterment this advice as of the date of this columnist absolution and does not undertake any obligation to amend any advanced statements as a aftereffect of new information, approaching contest or otherwise.
Niihara, Y, et al. A Appearance 3 Balloon of L-Glutamine in Sickle Corpuscle Disease. NEJM to be arise 19 July 2018
LaVoieHealthScienceKatie GallagherOffice: 617-374-8800 x109Mobile: [email protected]
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