INDIA – Dr. Reddy’s Laboratories Limited has introduced a new combination product for the treatment of type 2 diabetes in the United States.

In a press statement, Dr. Reddy’s Laboratories Ltd. said that the new drug combo contains two active ingredients, saxagliptin and metformin hydrochloride (extended-release).

Saxagliptin is a member of a class of medicines called DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors), and metformin belongs to a class of medicines called biguanides.

As a result, saxagliptin and metformin work together to lower blood sugar levels in patients with type 2 diabetes mellitus.

Dr. Reddy’s Laboratories Ltd. will sell its saxagliptin and metformin hydrochloride extended-release diabetes medication in the form of tablets.

The combination product will be supplied in the tablet strength of 2.5 mg/1000 mg in bottle count of 60 and tablet strength of 5 mg/500 mg and 5 mg/1000 mg each in bottle counts of 30.

Commenting on the combination product, Dr. Reddy’s Laboratories Ltd. stated: “It is the generic version of KOMBIGLYZE XR (saxagliptin and metformin hydrochloride extended-release) tablets, approved by U. S. Food and Drug Administration (FDA).”

This drug launch comes shortly after Onglyza (saxagliptin tablets) and Kombiglyze XR tablets, developed by AstraZeneca, were permanently discontinued in the United States.

A recent posting on the FDA Drug Shortages tracker indicates that both products were discontinued because of a business decision and not due to safety or efficacy-related concerns.

Both treatments are indicated for use as an adjunct to diet and exercise to improve glycaemic control in patients with type 2 diabetes.

Consequently, Dr. Reddy’s presents an alternative treatment option to better serve the needs of diabetic patients in the United States.

It aligns with the goal of Dr. Reddy’s to provide patients with access to a wider range of products at affordable prices.

When on the US market, Dr. Reddy’s Saxagliptin and Metformin Hydrochloride Extended-Release Tablets will join commonly prescribed anti-diabetics including Novartis AG’s drug Galvus and Boehringer Ingelheim/Eli Lilly’s Tradjenta.

The combination product also joins Merck & Co’s Januvia, which is currently the only DPP-4 inhibitor approved in both the United States and Europe.

With new combinations, the Indian drug firm will go head-to-head with Bristol Myers Squibb’s global diabetes business, developed through its collaboration partner AstraZeneca.

BMS’ global diabetes business, developed through its collaboration with AstraZeneca, includes Onglyza, Kombiglyze XR/Komboglyze, and dapagliflozin (marketed as Forxiga outside the United States).

Moreover, Dr. Reddy’s Laboratories is exploring new spaces such as integrated digital healthcare services, digital therapeutics, and disease management.

The company plans to bolster operating efficiency, drive productivity, improve operations and processes to increase efficiency and responsiveness, enhance quality systems, strengthen Research & Development efforts, and invest in digital initiatives to get closer to customers worldwide.

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