FDA OKs Three Merck/Pfizer Drugs for Type-2 Diabetes

An SGLT2 inhibitor and two fixed-dose combinations will be available in January and February 2018

The FDA has approved three new drugs for type-2 diabetes: Steglatro tablets (ertugliflozin), an oral sodium-glucose cotransporter 2 (SGLT2) inhibitor; Steglujan tablets (ertugliflozin/sitagliptin), the only fixed-dose combination of an SGLT2 inhibitor and the dipeptidyl peptidase-4 inhibitor sitagliptin; and Segluromet tablets (ertugliflozin/metformin hydrochloride), a fixed-dose combination. The drugs are a joint venture between Merck and Pfizer.

Steglatro (available in 5-mg and 15-mg tablets) is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type-2 diabetes mellitus. Steglujan, which combines 5 mg or 15 mg ertugliflozin with 100 mg of sitagliptin, is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type-2 diabetes mellitus when treatment with both ertugliflozin and sitagliptin is appropriate. Segluromet, which combines 2.5 mg or 7.5 mg ertugliflozin with 500 mg or 1,000 mg of metformin hydrochloride, is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type-2 diabetes mellitus who are not adequately controlled on a regimen containing ertugliflozin or metformin, or in patients who are already treated with both ertugliflozin and metformin.

These medications are not recommended in patients with type-1 diabetes mellitus or for the treatment of diabetic ketoacidosis. Segluromet contains a boxed warning for lactic acidosis. The full prescribing information for each product should be consulted for complete warnings, precautions, and contraindications.

These FDA approvals are supported by seven phase 3 studies of approximately 4,800 patients.

In 2013, Merck and Pfizer announced that they entered into a worldwide collaboration, except Japan, for the co-development and co-promotion of ertugliflozin. The Merck sales force will exclusively promote Steglatro and the two fixed-dose combination products in the United States. Merck and Pfizer will share potential revenues and certain costs on a 60/40 basis, respectively, and Pfizer may be entitled to additional milestone payments.

Merck has established a list price (wholesale acquisition cost) of $8.94 per day for Steglatro, $17.45 per day for Steglujan, and $8.94 per day for Segluromet. Wholesale acquisition costs do not include discounts that may be paid on the products. Steglatro and Steglujan are expected to be available in pharmacies in January 2018. Segluromet is expected to be available in February 2018.

Source: Merck; December 22, 2017.