Furiex Pharmaceuticals, Inc. (NASDAQ: FURX) today confirmed that Takeda Pharmaceutical Company Limited (Takeda) announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion for VIPIDIA™ (alogliptin) and Fixed-Dose Combinations VIPDOMET™ (alogliptin and metformin) and INCRESYNC™ (alogliptin and pioglitazone) for the treatment of Type 2 diabetes patients who are uncontrolled on existing therapies. This opinion is a key step toward getting marketing authorization in EU countries, Norway and Iceland.
The CHMP opinion was based on data from a clinical trial program involving more than 11,000 patients treated for up to four years, including the one-year data from the ENDURE
trial and interim data from the cardiovascular outcomes trial EXAMINE
The efficacy of alogliptin was studied as an adjunct to diet and exercise as an add-on therapy to several other classes of anti-diabetic medications, including metformin, pioglitazone, insulin and sulfonylureas (SUs). In these studies, alogliptin 25 mg tablets taken once-daily demonstrated clinically and statistically significant reductions in HbA1c, with a good overall tolerability profile and low incidence of hypoglycemia compared with active control or placebo.
Under its agreement with Takeda, Furiex is entitled to receive a $10 million regulatory milestone payment for the first EU marketing authorization of an alogliptin product, plus royalties on all alogliptin product sales in the EU and potential sales-based milestones.
“This positive opinion is an important achievement for Furiex and our partner, Takeda, in our mutual efforts to meet the needs of this growing patient population,” said June Almenoff, M.D., Ph.D., president and chief medical officer of Furiex. “These treatment options should further assist clinicians to tailor treatment to individual patient needs and help improve outcomes.”
* Efficacy and Safety of Alogliptin Plus Metformin Compared to Glipizide Plus Metformin in Subjects With Type 2 Diabetes Mellitus;
† EX amination of C A rdiovascular Outco M es: Aloglipt IN vs. Standard of Car E in Patients with Type 2 Diabetes Mellitus and Acute Coronary Syndrome
As previously announced, on January 25, 2013 these three new Type 2 diabetes therapies were approved by the U.S. Food and Drug Administration under the brand names Nesina® (alogliptin), Kazano® (alogliptin and metformin) and Oseni® (alogliptin and pioglitazone).