FDA Approves New Type 2 Diabetes Drug From Merck, Pfizer

The U.S. Food and Drug Administration approved Merck’s and Pfizer’s Steglatro (ertugliflozin), a sodium-glucose co-transporter 2 (SGLT2)- inhibitor, that will square off against established drugs in the market.

Although the FDA has posted the approval on its website under the Approved Drugs Products page, neither Pfizer nor Merck have yet to issue a release about the FDA decision. In March, the two companies submitted three New Drug Applications for medicines containing the SGLT2- inhibitor to help improve glycemic control in adults with type 2 diabetes. One NDA was as a monotherapy, one was a fixed-does combination of ertugliflozin and Merck’s Januvia (sitagliptin), and the final one was for a fixed-dose combination of ertugliflozin and metformin, a drug that helps patients control blood-sugar levels. Januvia is a DPP-4 (dipeptidyl peptidase) inhibitor and dominates that market. DPP-4 inhibitors work by reducing glucagon and blood glucose levels by increasing levels of incretin in type 2 diabetes patients. By inhibiting SGLT2, diabetes patients are able to excrete excess glucose through their urine.

Data for the three NDAs was supported by clinical trials with approximately 12,600 adults with type 2 diabetes.

Merck and Pfizer teamed up in 2013 to develop ertugliflozin. In an emailed statement provided to Reuters, both companies said the plan is for Steglatro to become commercially available by early 2018. Under terms of the collaboration, Merck will be responsible for commercializing the drug in the United States, Reuters noted.

With the FDA approval, Reuters noted that Steglatro will go head-to-head in the space with other SGLT2- inhibitors such as AstraZeneca’s Farxiga, Johnson & Johnson’s Invokana and Eli Lilly and Boehringer Ingelheim’s Jardiance. Jardiance is the only type 2 diabetes medicine that was approved to reduce the risk of cardiovascular death in patients with type 2 diabetes, which gives it a strong platform in the market space.

Analysts are forecasting sales of Steglatro to be more than $1 billion, however the companies will need to show similar cardiovascular results in order to be truly competitive, Reutersreported.

The most common form of diabetes is type 2 diabetes which causes blood sugar levels to rise higher than normal. More than 30 million Americans are estimated to have diabetes, with about 90 percent being diagnosed with type 2 diabetes, according to the U.S. Centers for Disease Control. People with diabetes are likely to develop additional complications including cardiovascular issues. Diabetes is the leading cause of kidney failure and is the 7th leading cause of death in the United States.