FDA has until December 2017 to act on the applications, which include a combination of the SGLT2 inhibitor and the top-selling Januvia.
Merck and Pfizer today announced that FDA has accepted new drug applications (NDAs) for the sodium glucose co-transporter-2 (SGLT2) inhibitor ertugliflozin, both as monotherapy and in fixed-dose combinations with metformin and with sitagliptin, the blockbuster type 2 diabetes (T2D) medication sold by Merck as Januvia.
The FDA deadlines for acting on the applications are in December 2017. The companies also announced that the European Medicines Agency (EMA) will review marketing applications for the 3 therapies.
“The acceptance of the three applications by both the FDA and EMA represents an important milestone in the progression of our collaboration with Pfizer on ertugliflozin, and reflects Merck’s commitment to advancing new treatment options for people with type 2 diabetes around the world,” Sam Engel, MD, associate vice president, Merck clinical research, diabetes and endocrinology, said in a statement. “If approved, we believe ertugliflozin will be an important option for many patients and a welcome addition to our already strong type 2 diabetes portfolio, with our DPP-4 [dipeptidyl peptidase-4] inhibitor Januvia as the foundation.”
Last month, Merck and Pfizer announced publication of positive results for ertugliflozin, the SGLT2 inhibitor they are developing jointly to compete in the class. Results of the trial, VERTIS MONO, showed meaningful A1C reductions at 26 weeks.
The companies have expanded the cardiovascular (CV) outcomes trial, VERTIS CV, after another SGLT2 inhibitor, empagliflozin, showed CV benefits, and CV trial results for the best-selling SGLT2 inhibitor, canagliflozin, are anticipated before the end of 2017. While the SGLT2 inhibitor market is competitive, ertugliflozin offers the prospect of combining a new entrant with a popular therapy, the DPP-4 sitagliptin.
“Because type 2 diabetes is a progressive disease, patients may need multiple treatment options to help them manage their condition,” said James Rusnak, MD, PhD, chief development officer, cardiovascular and metabolic diseases, Pfizer Global Product Development. "That is why we are proud of the comprehensive VERTIS clinical development program, and we look forward to working closely with the FDA and EMA in an effort to bring these 3 additional treatment options to adults with type 2 diabetes."
SGLT2 inhibitors have a mechanism of action that secretes blood glucose through the urinary tract. While not approved for weight loss or to reduce hypertension, studies have shown that the class has positive effects on both. The unique effect allows SGLT2 inhibitors to combine well with other T2D therapies, including insulin, DPP-4 inhibitors and glucagon-like peptide-1 receptor agonists.
Glyxambi, which combines the SGLT2 inhibitor empagliflozin and the DPP-4 inhibitor linagliptin, is already approved by FDA, and Qtern was just approved. The roster of combinations for T2D also include those with SGLT2 inhibitors and metformin. In May 2016, FDA approved Invokamet, which combines metformin with canagliflozin, for use as a first-line therapy after previously approving it for patients who were already being treated for T2D.