- The Food and Drug Administration gave the green light to Merck & Co. and Pfizer Inc.’s type 2 diabetes drug ertugliflozin earlier this week.
- The SGLT-2 inhibitor will be sold by Merck in the U.S. under the name Steglatro, and is expected to enter the market in early 2018.
- Beyond the monotherapy, the regulatory agency also approved ertugliflozin in fixed-dose combination with Merck’s blockbuster diabetes medication Januvia (sitagliptin) and the commonly used generic metformin. The medications will be known as Steglujan and Segluromet, respectively.
Ertugliflozin was developed in-house by Pfizer, and the two big pharmas partnered on its development in 2013. The deal was meant to help bolster Merck’s blockbuster Januvia franchise. The DPP-4 inhibitor has long been one of the New Jersey pharma’s best-selling drugs, but has faced increased competition from new classes of drugs for diabetes in recent years. Merck has been looking for ways to extend the lifecycle of the product by creating fixed-dose combinations.
Januvia is still the company's best-selling drug with sales of $4.4 billion in the first nine months of this year, but revenues have been declining every quarter this year. The franchise, which also includes a fixed-dose combo of Januvia and metformin, brought in $6.1 billion in 2016, but sales were virtually flat year-over-year.
Merck said in a statement to BioPharma Dive that the list price for Steglatro will be $8.94 per day, while the combination with Januvia will have a list price of $17.45 per day. The metformin combo will also cost $8.94 daily.
While the SGLT-2 class is relatively new, it has quickly become crowded. Johnson & Johnson brought the first of these to market in 2013, introducing its Invokana (canagliflozin). There are now also offerings from Eli Lilly & Co. and AstraZeneca plc.
Lilly recently gained FDA approval for an expanded label for its Jardiance (empagliflozin) that says it helps prevent major cardiovascular issues. While this was meant to be a huge boon for Lilly to set apart its med from the competition, the effect is largely thought to occur class-wide and has had little impact on marketshare of the drugs in the space. J&J's Invokana has also shown cardio-protective effects in studies and maintains its market- leading position.
Payer decisions could have a greater impact on these drugs —CVS Health announced earlier this year that it has excluded Jardiance from its preferred formulary list in favor of Invokana.