FDA Endorses 3 New Drug Applications (NDAs) From Merck & Co., Inc. (MRK), Pfizer Inc. (PFE)

The U.S. Food and Drug Administration (FDA) has acknowledged the filing for review of three New Drug Applications (NDAs) from Merck & Co., Inc. (NYSE:MRK) and Pfizer Inc. (NYSE:PFE). The medicines, which will be used for the improvement of glycemic control in adults with type 2 diabetes, contain ertugliflozin, an investigational SGLT2 inhibitor.

The FDA allocated December 2017 as the Prescription Drug User Fee Act (PDUFA) accomplishment date for the three NDAs.

The three included monotherapy, a fixed-dose combination of ertugliflozin and JANUVIA® (sitagliptin) and another fixed-dose combination of ertugliflozin and metformin.

In appreciation of the FDA’s approval, Merck’s associate vice president for clinical research, diabetes, and endocrinology Sam Engel states, “The acceptance of the three applications by both the FDA and EMA represents an important milestone in the progression of our collaboration with Pfizer Inc. (NYSE:PFE) on ertugliflozin.”

The Approval Of Ertugliflozin Could Be An Important Option For Many Patients

There are many ways of looking at the consequences of having ertugliflozin approved. Engel points out that it is a strong addition to the company’s already solid type 2 diabetes portfolio. Hence it will be an optional treatment. On the other hand, it also demonstrates Merck & Co., Inc. (NYSE:MRK)’s commitment to helping people with type 2 diabetes around the globe.

Chief development officer, Pfizer Global Product Development James Rusnak echoes Engel’s sentiments citing that type 2 diabetes is a progressive disease. Thus patients may desire to have multiple treatment options in managing various associated conditions.

The Marketing Applications Have The Support Of The VERTIS Clinical Improvement Program

The packed VERTIS clinical program is made up of nine Phase 3 trials, which involved close to 12,600 adults suffering from type 2 diabetes. On the other hand, Engel acknowledges that they are optimistic about the approval of ertugliflozin and significant alongside DPP-4 inhibitor JANUVIA as the foundation.

However, JANUVIA, which works hand in hand with diet and exercise in improving glycemic control, has not been studied at large. Hence, it is important to exercise caution when using it. In the meantime, Merck & Co., Inc. (NYSE:MRK)’s stock closed at $65.96 on Tuesday following a fall of $0.59 or 0.77%. Pfizer Inc. (NYSE:PFE) closed the session at $33.99, a decline of $0.36 or 1.05%.

Note: This article is written by Adam Russell and was originally published at Market Exclusive.