Merck Co., Inc. MRK and Pfizer PFE presented data from phase III VERTIS CV cardiovascular (“CV”) outcomes study on SGLT2 inhibitor, Steglatro (ertugliflozin), at the American Diabetes Association’s virtual Scientific Sessions
The study evaluated Steglatro added to background standard-of-care treatment in patients with type 2 diabetes and atherosclerotic CV disease. Steglatro is currently approved as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Data from the study showed that Steglatro met the primary endpoint of the study of non-inferiority on major adverse CV events (“MACE”), which include a composite of CV death, nonfatal myocardial infarction or nonfatal stroke, versus placebo.
The primary MACE outcome was reported in 11.9% of patients treated with two doses of Steglatro — 5 mg and 15 mg — similar to placebo. However, the drug failed to achieve superiority compared to placebo in key secondary endpoints. The endpoints include time to first occurrence of the composite of CV death or hospitalization for heart failure ("HHF"); time to CV death alone, and time to first occurrence of the composite of renal death, dialysis/transplant or doubling of serum creatinine.
Data from this CV outcomes study are a significant and important addition to the overall evidence for the cardiovascular safety profile of Steglatro. The VERTIS CV study was designed to determine non-inferiority on CV safety of Steglatro to satisfy the FDA’s guidance of CV safety for novel anti-hyperglycemic agents in the pre-approval and post-approval time periods.
Shares of the company have lost 6.8% year to date compared with the industry’s decline of 5.3%.
Steglatro is a newer drug in Merck’s diabetes portfolio approved in 2018. Key drugs in Merck’s diabetes portfolio includes Januvia and Janumet, both approved for type 2 diabetes. The drugs generated worldwide sales of $1.28 billion in the first quarter of 2020.
Although diabetes is a lucrative market, there are several players fighting for space in this market. Novo Nordisk NVO is one of the companies with strong presence in the Diabetes care market. Moreover, Mylan MYL received approval for Semglee (insulin glargine injection) in vial and pre-filled pen presentations for controlling high blood sugar in adults with type 2 diabetes earlier this month.
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Merck currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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