Months after GlaxoSmithKline (GSK) applied for U.S. approval to market its once-weekly type 2 diabetes drug Albiglutide, the pharmaceutical company has applied to European regulators. GSK is hoping that approval for Albiglutide in the U.S. and Europe will give it opportunity to tap into the growing type 2 diabetes drug market.
Albiglutide is in the same class of injectable GLP-1 medications as Byetta and Bydureon, made by Bristol-Myers Squibb and AstraZeneca, and Novo Nordisk’s Victoza, now promoted by celebrity chef Paula Deen.
Albiglutide’s road to U.S. Food and Drug Administration (FDA) approval has been winding. Last November, a series of late-stage clinical trials showed that the drug did not reduce blood sugar levels as well as competitor Victoza. However, as more data was collected, the outlook began to look more promising for Albiglutide, with the drug performing favorably compared to Merck & Co’s Januvia. It also did not seem to increase the risk of cardiovascular events.
Drug regulators are particularly concerned about cardiovascular risks and other serious side effects associated with type 2 diabetes drugs. In 2010, the FDA severely restricted the use of Avandia after the drug was linked to fatal heart attacks. A year later, the agency warned that Actos had been tied to cases of bladder cancer.
If GSK wins approval for Albiglutide in the U.S., the drug could hit the market as early as 2014.