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Merck's Diabetes Drugs Get FDA Nod As Adjunct Therapies


Merck MRK along with Pfizer Inc. PFE announced that the FDA has approved its investigational oral SGLT-2 inhibitor, Steglatro (ertugliflozin) tablets, and Steglujan (ertugliflozin + sitagliptin) as an adjunct to diet and exercise for improving glycemic control in patients with type 2 diabetes mellitus.

Steglujan is a fixed combination of Steglatro and Januvia (sitagliptin), which is approved in patients who are eligible for treatment with the combination.

Apart from these two drugs, the FDA also approved Segluromet (ertugliflozin + metformin) for the same indication in patients already treated with Steglatro or Glucophage (metformin) with inadequately controlled type 2 diabetes mellitus and patients who are already treated with combination of ertugliflozin and metformin.

So far this year, shares of Merck have lost 4.3% compared with the industry's growth of 16%.


The FDA approved the drugs based on data from seven phase III studies, which evaluated Steglatro as monotherapy or in combination with Januvia and/or Bristol-Myers Squibb Company's BMY Glucophage. The studies also evaluated Steglatro in combination with insulin and a sulfonylurea. Data from the studies showed that Steglatro as a single agent or in combination with Januvia significantly reduced A1C level, a measure of blood glucose, compared to placebo.

Steglatro also significantly reduced body weight in patients who were already receiving a combination of Januvia and Glucophage versus placebo. The drug also achieved significant reductions in systolic blood pressure.

The approval of the three new drugs will boost Merck's diabetes portfolio, which comprises Januvia and Janumet. Both the marketed drugs have seen volume growth in the first nine months of 2017 and have generated sales of $4.4 billion.

However, Merck received a complete response letter from the FDA for supplemental New Drug Applications ("CRL"), seeking label expansion of Januvia, Janumet and Janumet XR in April 2017. The company is in discussion with the FDA to resolve the issues in the CRL. Moreover, Merck also received a setback earlier this month when its key immune-oncology drug, Keytruda, failed in a phase III gastric cancer study.

Zacks Rank & Stock to Consider

Merck carries a Zacks Rank #3 (Hold).

Corcept Therapeutics Incorporated CORT is a better-ranked health care stock, carrying a Zacks Rank #2 (Buy). You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here.

Corcept's earnings per share estimates have increased from 78 cents to 88 cents for 2018 over the last 60 days. The company delivered a positive earnings surprise in two of the trailing four quarters with an average beat of 14.32%. The company's stock is up 146.5% so far this year.

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