AstraZeneca and Bristol-Myers Squibb are celebrating the news that regulators on both sides of the Atlantic are reviewing dapagliflozin, potentially a first-in-class type 2 diabetes treatment.
The firms announced that the US Food and Drug Administration has accepted for review a New Drug Application for dapagliflozin, while a marketing authorisation application has also been validated by the European Medicines Agency. The submissions were filed in December and the Prescription Drug User Fee Act goal date for the FDA is October 28.
The filings include data of up to two years in duration "from a global development programme involving approximately 6,000 individuals in 40 clinical studies", AstraZeneca and B-MS said. The companies also noted that in accordance with FDA guidelines, the US application also includes data assessing the cardiovascular safety of dapagliflozin.
If approved, the drug would potentially be the first in a class of novel agents that inhibit sodium-glucose cotransporter-2 (SGLT2), a specific target located in the kidney. AstraZeneca noted that dapagliflozin is designed to help control glycaemia independently of insulin pathways, leading to the excretion of excess glucose and associated calories in the urine.
The Anglo-Swedish drugmaker sees dapagliflozin as a potential blockbuster which could help soften the blow of a number of patent expiries to some key drugs, notably the antiulcerant Nexium (esomeprazole), the antipsychotic Seroquel (quetiapine) and Arimidex (anastrozole) for breast cancer.
AstraZeneca signed a deal with B-MS in January 2007 to develop and commercialise dapagliflozin, and another diabetes compound Onglyza (saxagliptin), a dipeptidyl peptidase-4 inhibitor. The latter was approved n the USA and Europe 2009 but has failed to make inroads into the market; the drug brought in just $69 million in 2010.
However, last week, European regulators approved a licence extension for Onglyza, making it the first DPP-4 inhibitor to get the green light for the treatment of type 2 diabetics suffering from moderate or severe renal impairment. Last month, the FDA expanded the label on Onglyza to include information about the drug's safety and efficacy in patients with kidney failure.