Dear Valued Visitor,

We have noticed that you are using an ad blocker software.

Although advertisements on the web pages may degrade your experience, our business certainly depends on them and we can only keep providing you high-quality research based articles as long as we can display ads on our pages.

To view this article, you can disable your ad blocker and refresh this page or simply login.

We only allow registered users to use ad blockers. You can sign up for free by clicking here or you can login if you are already a member.

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.

Merck MRK

360b /

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.

Follow Merck & Co. Inc. (NYSE:MRK)
Trade (NYSE:MRK) Now!

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%.

Follow Pfizer Inc (NYSE:PFE)
Trade (NYSE:PFE) Now!

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

DOWNLOAD FREE REPORT: Warren Buffett's Best Stock Picks

Let Warren Buffett, George Soros, Steve Cohen, and Daniel Loeb WORK FOR YOU.

If you want to beat the low cost index funds by 19 percentage points per year, look no further than our monthly newsletter.In this free report you can find an in-depth analysis of the performance of Warren Buffett's entire historical stock picks. We uncovered Warren Buffett's Best Stock Picks and a way to for Buffett to improve his returns by more than 4 percentage points per year.

Bonus Biotech Stock Pick: You can also find a detailed bonus biotech stock pick that we expect to return more than 50% within 12 months.
Subscribe me to Insider Monkey's Free Daily Newsletter
This is a FREE report from Insider Monkey. Credit Card is NOT required.