Merck & Co. and Pfizer Leads Pipeline NewsBy
A roundup of the latest market developments from the pipelines of the pharmaceutical majors and other related news, featuring news from Merck & Co. and Pfizer.
Editor’s Note: This article is updated on a continuous basis for news announced from Wednesday March 1, 2017 to Tuesday March 7, 2017.
FDA, EMA Accept Merck & Co., Pfizer Filings for Diabetes Therapies
The US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have accepted three new drug filings from Merck & Co. and Pfizer for diabetes medicines containing Pfizer’s ertugliflozin, an investigational sodium-glucose cotransporter-2 (SGLT2) inhibitor in development to improve glycemic control in adults with Type 2 diabetes.
In the US, the companies filed three new drug applications (NDAs) with the FDA for ertugliflozin: one as monotherapy; one for a fixed-dose combination of ertugliflozin and Merck’s Januvia (sitagliptin), a dipeptidyl peptidase-4 inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus; and one for a fixed-dose combination of ertugliflozin and metformin, indicated as an adjunct to diet and exercise to improve glycemic control in adults and children with Type 2 diabetes mellitus. In Europe, the companies filed three marketing authorization applications (MAAs) with the EMA for the same indications.
The FDA has set a Prescription Drug User Fee Act action date in December 2017 for the three NDAs, and the EMA has validated for review the three MAAs.
Source: Merck & Co.