FDA approval of AstraZeneca orphan drug myalept

Source: China Council for the promotion of drugs, AstraZeneca, February 25, 2014, said Tuesday that the U.S Food and drug administration has approved myalept as an adjuvant diet replacement therapy for patients with leptin deficiency and complications of congenital or acquired systemic fat metabolism disorders Myalept is a recombinant analogue of human leptin [laboratory construction], which is the first and only drug approved by FDA to treat such diseases AstraZeneca said it was working to get myalept to patients in the United States as soon as possible Dyslipidemia is a rare form of adipocytopenia syndrome Some patients are hereditary, while others are due to pathophysiology and unknown causes The characteristic of generalized fat metabolism disorder is the general decrease of subcutaneous fat tissue This reduction in adipose tissue can lead to a lack of leptin, leading to a variety of metabolic complications The company said it was in the process of transferring myalept's biopharmaceutical license application from Squibb to ASCON as part of its February 1 acquisition of diabetes alliance assets, including myalept and amylin pharmaceuticals AstraZeneca said the safety and efficacy of myalept in the treatment of complications of local fat metabolism disorders or liver diseases, including nonalcoholic steatohepatitis (NASH), had not been established The company also said that myalept's indications do not include the treatment of fat metabolism disorders in HIV patients, metabolic diseases including diabetes and hypertriglyceridemia without congenital or acquired evidence of systemic fat metabolism disorders The black box warning in myalept's manual indicates that the antibody will neutralize its activity and warn of the risk of lymphoma Original link: http://www.rttnews.com/2275609/astrazeneca-says-fda-approvals-orphan-drug-myalert-quick-facts.aspx