Furiex Pharmaceuticals, Inc. (NASDAQ: FURX) today confirmed that Takeda Global Research & Development Centre (Europe) Ltd. received confirmation from the European Medicines Agency (EMA) of the acceptance of submissions of Marketing Authorization Applications (MAAs) for alogliptin and pioglitazone combined in a single tablet and alogliptin and metformin combined in a single tablet. The EMA has confirmed that these submissions have been validated for assessment.
Under Furiex's agreement with Takeda, these submissions do not trigger a milestone payment to Furiex. However, if approved, Furiex is entitled to receive royalty payments on sales of these products.
“We are pleased that the EMA has accepted to review Takeda’s MAA submissions for the two fixed dose combination therapies using alogliptin, which follow close behind the acceptance to review the MAA for alogliptin”, said June Almenoff, M.D., Ph.D., president and chief medical officer of Furiex.
Added Fred Eshelman, Pharm.D., chairman of Furiex, “These filings represent another important milestone for alogliptin and brings us one step closer to offering two more treatment options for patients with type 2 diabetes.”
About Type 2 Diabetes
Type 2 diabetes is the most common form of diabetes and has reached epidemic proportions globally. The global health care expenditures to treat and prevent diabetes and its complications were estimated at $376 billion in 2010. By 2030, this number is projected to exceed $490 billion. In addition to diet and exercise, patients often need to take multiple medications to help manage blood glucose. Because of the chronic nature of this disease, combination therapy is almost uniformly required to maintain diabetic control over many years of therapy.
Alogliptin is a DPP-4 inhibitor being investigated in the U.S., as an adjunct to diet and exercise, for the treatment of type 2 diabetes. DPP-4 inhibitors address insulin deficiency by slowing the inactivation of incretin hormones GLP-1 (glucagon-like peptide-1) and GIP (glucose-dependent insulinotropic peptide). As a result, an increased amount of active incretins enables the pancreas to secrete insulin in a glucose-dependent manner, thereby assisting in the management of blood glucose levels. A New Drug Application (NDA) for alogliptin was approved in April 2010 by the Japanese Ministry of Health, Labour and Welfare for the treatment of type 2 diabetes, and the therapy is currently available under the brand name NESINA® in this market.