Furiex Pharmaceuticals, Inc., a drug development collaboration company, confirmed that Takeda Global Research & Development Centre (Europe) Ltd. has 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, MD, PhD, 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.”
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 US, 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.
Alogliptin/pioglitazone is a fixed dose combination therapy indicated for the treatment of type 2 diabetes, which combines alogliptin and pioglitazone in a single tablet. Pioglitazone is a thiazolidinedione or TZD, marketed by Takeda as ACTOS, that directly targets insulin resistance, a condition in which the body does not efficiently use the insulin it produces to control blood glucose levels. It is currently approved for use in adults for the treatment of type 2 diabetes as an adjunct to diet and exercise. An NDA for the alogliptin/pioglitazone fixed-dose combination was approved in July 2011 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 LIOVEL in this market.
Alogliptin/metformin is a fixed-dose combination therapy which combines the benefits of alogliptin with metformin in a single tablet, for the treatment of type 2 diabetes. Metformin is a member of the biguanide class of oral hypoglycemic and is the usual first-line therapy in addition to diet and exercise. It acts primarily by reducing the amount of glucose produced by the liver. Alogliptin and metformin work in combination to help patients with type 2 diabetes manage their blood glucose levels.
Furiex Pharmaceuticals is a drug development collaboration company that uses innovative clinical development design to accelerate and increase value of drug development programs by advancing them through the drug discovery and development process in a cost-efficient manner.