Merck and Pfizer update on ertugliflozin regulatory filings

7 March 2017

The US Food and Drug Administration has accepted for review three New Drug Applications (NDAs) for medicines containing ertugliflozin, an investigational SGLT2 inhibitor in development to help improve glycemic control in adults with type 2 diabetes filed by US pharma giants Merck & Co (NYSE: MRK) and Pfizer (NYSE: PFE).

The companies entered into a worldwide (except Japan) collaboration agreement for the development and commercialization of Pfizer’s ertugliflozin in 2013. The deal saw an upfront payment to Pfizer of $60 million.

Of the three NDAs, one is for monotherapy, one for the fixed-dose combination of ertugliflozin and Merck’s Januvia (sitagliptin), and one for the fixed-dose combination of ertugliflozin and metformin. The Prescription Drug User Fee Act (PDUFA) action date from the FDA is in December 2017 for the three NDAs. Additionally, the European Medicines Agency has validated for review three Marketing Authorization Applications (MAAs) for ertugliflozin monotherapy and the two fixed-dose combination products.

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