The U.S. Food and Drug Administration has approved Steglatro (ertugliflozin), a new SGLT2 inhibitor developed through a Merck and Pfizer collaboration, for improving glycemic control in adults with type 2 diabetes. The approval includes both the monotherapy and two combination products, positioning the companies to compete in the increasingly important diabetes market.
Strategic Pricing in a Competitive Market
In a notable market strategy, Merck and Pfizer have priced Steglatro aggressively at $3,263 annually ($8.94 per day) for the monotherapy and metformin combination, significantly undercutting established competitors. This pricing positions Steglatro favorably against AstraZeneca's Farxiga at $11.57 per day and Eli Lilly/Boehringer's Jardiance at over $13 per day.
The fixed-dose combination Steglujan, which pairs ertugliflozin with Merck's successful DPP-4 inhibitor sitagliptin (Januvia), will be available at $6,329 per year. Both Steglatro and Steglujan are scheduled for immediate market release, while the metformin combination Segluromet will follow in the coming month.
Treatment Options and Market Dynamics
The approval provides physicians with three new treatment options:
- Steglatro (ertugliflozin) as monotherapy
- Steglujan (ertugliflozin + sitagliptin) for patients requiring dual therapy
- Segluromet (ertugliflozin + metformin) as a combination treatment
This launch represents a strategic expansion for Merck, which already dominates the oral diabetes market with its DPP-4 inhibitor franchise Januvia and Janumet. The collaboration with Pfizer, established in 2013, covers global markets except Japan, with Merck's sales force exclusively promoting the products in the U.S. The companies will share revenues and costs on a 60/40% basis, with Pfizer eligible for additional milestone payments.
Cardiovascular Outcomes Focus
A critical factor in the competitive landscape of diabetes medications is cardiovascular benefit data. Eli Lilly/Boehringer's Jardiance currently holds a significant advantage as the first diabetes drug approved to reduce cardiovascular death risk in high-risk diabetes patients.
Merck and Pfizer are addressing this through the ongoing Vertis CV Study, which is evaluating cardiovascular outcomes in 8,000 diabetes patients with vascular disease. Results are expected by October 2019, and positive findings could significantly influence Steglatro's market position.
The European approval decision is pending, which will be crucial for the drug's global commercial potential. As diabetes management increasingly focuses on both glycemic control and cardiovascular risk reduction, the success of Steglatro and its combinations will likely depend on both their competitive pricing and forthcoming cardiovascular outcomes data.
