Astrazeneca's diabetes drug wins approval from FDA advisory committee

13th Dec 2013 07:39

Drug maker AstraZeneca, in partnership with Bristol-Myers Squibb, on Friday revealed that the US Food and Drug Administration's (FDA) Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) gave its approval of their diabetes treatment, dapagliflozin. The FDA takes the EMDAC's advice into account when reviewing the companies' application. The EMDAC examined data from the global clinical development programme and decided that the benefits of dapagliflozin use outweigh identified risks and agreed to support the marketing of dapagliflozin as an adjunct to diet and exercise to improve glycaemic control in adults with type-2 diabetes mellitus. The Prescription Drug User Fee Act (PDUFA) goal date for dapagliflozin is January 11th 2014. The randomised, double-blind, placebo-controlled study of more than 17,000 patients initiated enrolment in April 2013 and has an anticipated completion date of 2019, AstraZeneca said. The study examined patient populations which covered the range of diabetes progression, including drug-naïve patients, patients inadequately controlled on oral therapies and patients on insulin-based regimens. The programme also provided significant experience in elderly patients, patients with a history of cardiovascular disease, overweight and obese patients, patients with poorly controlled hypertension and patients with mild to moderate renal impairment. NR