On July 26, AstraZeneca and Bristol-Myers Squibb (B-MS) announced that the U.S. Food and Drug Administration (FDA) acknowledged the receipt of the New Drug Application (NDA) resubmission for investigational drug dapagliflozin for the treatment of adults with type 2 diabetes. The FDA assigned a new Prescription Drug User Fee Act (PDUFA) date of January 11, 2014.
This resubmission relates to a Complete Response Letter (CRL) issued by the FDA at the end of January 2012. The NDA resubmission includes several new studies and additional long-term data (up to four years duration) from previously submitted studies. According to B-MS company statements, the new NDA will address safety issues brought up at an advisory committee hearing.
What is really interesting here is how will physicians react if and when the dapagliflozin enters the market and how will this affect patient share for Invokana (canagliflozin), another SGLT-2 from Janssen Pharmaceuticals. Also, in which line of type 2 diabetes treatment will these products find use And finally, what is the level of concern with regard to urinary tract infections for both products
We will be covering these and many other questions in the upcoming TreatmentTrends: Type 2 Diabetes report that will be fielding in mid-August with 100+ U.S. endocrinologists and 50+ U.S. PCPs.
For now, a Physician and Payer Forum (PPF) Novel Injectable Therapies for Type 2 Diabetes: What U.S. Market Access Hurdles Will Novel GLP-1 Receptor Agonists and Next-Generation Insulin Therapies Have to Clear (November 2012)provides some insight into these questions. For example, this report found that nearly 80 percent of surveyed endocrinologists (n=71) are familiar with the MOA of SGLT-2 inhibitors but the same was true for only 30 percent of surveyed PCPs (n=72). We may conclude that because they treat a broader base of patients, and not just those with metabolic conditions, surveyed PCPs may lack familiarity with this emerging drug class. However, both physician types seem to agree that an SGLT-2 will be prescribed alongside insulin.
The TreatmentTrends type 2 diabetes report, publishing in October 2013, will provide an up-to-date view on the issues explored in the 2012 PPF, expanding on the above findings, and providing greater detail on physician familiarity, interest and the percent of patients likely to be candidates for late-stage type 2 diabetes therapies. Meanwhile, the Decision Resources Pharmacor Type 2 Diabetes (Event Driven) report estimates that both products will achieve over a billion in U.S. sales by 2021 especially with the availability of fixed-dose combinations with metformin making this new class a major contributor to the type 2 diabetes market.
Rob Dubman is a Director on the Cardiovascular, Metabolic and Renal Disorders team at Decision Resources Group.