The U.S. FDA approved Steglatro (ertugliflozin) from MSD and Pfizer to treat type 2 diabetes. This is not only the first new diabetic drug approved in just one month (another heavy-duty diabetic new drug is approved once weekly), but also the 45th new drug approved by the FDA this year.
Type 2 diabetes treated with this approved new drug is the most common type of diabetes in the world, accounting for 90% -95% of the total number of cases. The reason for such diseases is that the patient can not produce enough insulin, or the body's sensitivity to insulin decreases, resulting in the patient losing the normal ability of blood sugar regulation. Patients with type 2 diabetes are at high risk of developing a series of serious complications, presenting a 2-4 times greater risk of cardiovascular disease than the average person and urgently need more glycemic control.
In recent years, SGLT2 inhibitors with a new mechanism of action have drawn the attention of the field of diabetes treatment. These new drugs act on the SGLT2 transporter in the body to prevent the resorption of filtered glucose in the kidneys, effectively controlling blood sugar levels. The good news is that this treatment is not dependent on insulin. Currently, a number of SGLT2 inhibitors have been approved.
Ertugliflozin, brought by MSD and Pfizer, also showed good efficacy and safety in clinical trials. In June, the two companies released excellent data from two Phase 3 clinical trials: ertugliflozin significantly reduced patients compared with placebo-controlled patients, either with metformin or with Januvia (sitagliptin) Glycated hemoglobin (HbA1c) levels. Based on these results, the U.S. FDA has given a green light to these two combination therapies. In addition, the FDA approved the monotherapy of ertugliflozin.
As Dr Sam Engel, MSD's vice president for diabetes and endocrinology, puts it, "the new drug has" excellent efficacy and safety "both as a monotherapy and in combination with sitagliptin. This is also expected to make this new drug to meet the patient's treatment needs.
Next year, the new drug will officially enter the U.S. market. We look forward to this new mechanism of new diabetes drugs can give patients more treatment options!