British-Swedish drugmaker AstraZeneca has been approved by the FDA for its once-a-day Xigduo XR extended-release tablet to treat adults with type 2 diabetes mellitus in the United States. AstraZeneca’s once-daily tablet is indicated as an adjunct therapy to diet and exercise to improve glycaemic control. Xigduo XR is already approved in Australia, and Xigduo is approved in the European Union.
The Xigduo FDA approval gives the two anti-hyperglycaemic agents, dapagliflozin and metformin, a green light to be used as a once-daily oral tablet. Dapagliflozin is an inhibitor of sodium-glucose cotransporter 2 (SGLT2) and metformin hydrochloride is a biguanide, which decreases glucose production and improves the body’s response to insulin.
SGLT2 inhibitors are a new class of medicines that remove glucose from the body through the kidneys. In 2013, Johnson & Johnson’s canagliflozin/metformin combo was the first to win an FDA approval for the SGLT2 class of drugs. Then after a long battle, Eli Lilly and Boehringer Ingelheim finally won approval for empagliflozin. Meanwhile, Pfizer and Merck are still working through late-stage trials with the competing ertugliflozin.
However, safety worries have thus far limited uptake for the SGLT2 class, as the treatments have been linked to increased rates of genital and urinary tract infections, plus kidney damage and cardiovascular issues. As a result, peak sales estimates for the class of drugs have been erratic, with some pegging their potential north of $5 billion and others expecting cumulative revenue more in line with $2 billion a year.
LGM Pharma provides the two anti-hyperglycaemic agents dapagliflozin and metformin hydrochloride for research and development purposes, and offers clients continued support throughout the R&D process. Type 2 diabetes is the most common form of diabetes affecting patients globally, and the United States alone has over 23 million people suffering from this condition. Continued research and development of new and innovative treatments to combat this ever growing patient population is not only prudent, but also extremely necessary.
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