FDA approves alogliptin for type 2 diabetes as three separate preparations

Source: FDA Area: News The FDA has approved alogliptin for the treatment of type 2 diabetes as three separate preparations: alogliptin monotherapy; alogliptin in combination with metformin; and alogliptin in combination with pioglitazone.   Alogliptin stimulates insulin release following meals and was shown to be safe and effective as monotherapy in 14 clinical trials involving approximately 8,500 patients with type 2 diabetes.  Alogliptin monotherapy reduced glycosylated haemoglobin (HBA1c) by 0.4 to 0.6% compared to placebo following 26 weeks of treatment.   The FDA has requested additional data due to caution about the cardiac safety of diabetes medication. This includes five postmarketing studies for alogliptin monotherapy of which a cardiovascular outcomes study is necessary to ensure that the drug does not increase the risk of heart attack or stroke. Other required post-marketing data includes incidence of liver impairment, serious cases of pancreatitis, and severe ...
Source: NeLM - News - Category: Drugs & Pharmacology Source Type: news