French drug maker Sanofi-aventis says that results from a Phase III trial of its experimental type 2 diabetes drug lixisenatide show that the drug successfully lowered patients' blood glucose levels and body weight, but did not increase the risk of hypoglycemia.
A study released in late June has brought some welcome news to the makers of Byetta and Januvia: Users of the two diabetes drugs run no greater risk of developing pancreatitis than people with diabetes who take other drugs. In fact, both drugs seem to put users at slightly less risk for the condition.
Amylin Pharmaceuticals has announced that it expects to begin selling a once-weekly version of its diabetes drug, Byetta, by the end of the year. The company reports that the FDA is nearing final inspections of its manufacturing plant and could give the go-ahead for U.S. sales in early March.
Most clinical studies of new drugs are conducted primarily on white men, whether or not they are most affected by the disease the drug is intended to treat. African Americans, for example, are 1.6 times more likely to have diabetes than non-Hispanic whites. Why should we assume that what works for white males will also be effective for African Americans, Hispanics, Asians, or, for that matter, women?
High percentages of endocrinologists, primary care physicians, and managed care organizations surveyed by a research firm say they would like to see additional GLP-1 analogues like Amylin/Eli Lilly's Byetta® and DPP-IV inhibitors like Merck's Januvia® available to treat type 2 diabetes.
It has been an interesting month for San Diego-based Amylin Pharmaceuticals Inc., the co-manufacturer of Byetta (exenatide) with Eli Lilly & Co., and Alkermes Inc. First, the company announced that it will reduce its sales force by 35 percent-200 employees-in hope of saving $20 million this year and $45 million annually starting in 2010. The company plans to retain 325 representatives to sell its diabetes products to doctors and endocrinologists. At the same time, Amylin has petitioned the FDA to approve the marketing of Byetta LAR, a form of the type 2 drug that requires injection only once a week.
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