Red seal and imprint "FDA APPROVED" on white surface. FDA - Food and Drug Administration is a federal agency of the United States Department of Health and Human Services.

Red stamp and imprint "FDA APPROVED" on a white surface.  FDA - The Food and Drug Administration is a federal agency within the United States Department of Health and Human Services.

A drug that has recently won its own first regulatory approval as a way to control blood glucose in cats is already approved to treat type 2 diabetes in humans.

The FDA has approved TheracosBio drug bexagliflozin, in addition to diet and exercise, as a way to improve blood sugar control in adults with type 2 diabetes. Privately held Theracos, based in Marlborough, Mass., will market its once-daily pill under the name “Brenzavvy” .

Brenzavvy is a small molecule designed to block sodium-glucose cotransporter 2 (SGLT2), a protein that allows the kidneys to absorb glucose. Blocking SGLT2 prevents this absorption, leading to excretion of glucose in the urine. The FDA decision only covers adults 18 and older. In the approval letter sent to the company Friday afternoon, the agency said it was delaying a decision on the drug’s use in patients ages 10 to 17 because the pediatric study had not been completed.

The FDA’s approval of Brenzavvy was based on the results of a Phase 3 program that evaluated the drug both as a monotherapy and as an adjunct to standard diabetes treatments such as metformin, a first-line diabetes drug. TheracosBio reported that the drug showed significant reductions in hemoglobin A1c, a measure of blood glucose, after 24 weeks. Clinical trial results also showed “moderate reductions” in weight and blood pressure. Similar findings in tests of other diabetes drugs have prompted pharmaceutical companies to seek additional approval for these indications.

TheracosBio drug joins the class of SGLT2 inhibitors, some of which are blockbusters. AstraZeneca reported $3 billion in 2021 sales for its SLGT2 inhibitor, Farxiga. Eli Lilly’s Jardiance sales for that year were nearly $1.5 billion. Johnson & Johnson’s Invokana sales are $563 million in 2021. SLGT2-blocking drugs carry risks of potentially serious side effects. Like other drugs in the class, Brenzavvy’s label includes warnings about ketoacidosis, a complication in which the blood becomes acidic. Other caveats include a higher incidence of lower limb amputations and low blood pressure.

Brenzavvy will be available as a 20 mg tablet, which is a higher dose than the version of bexagliflozin approved by the FDA to treat cats with diabetes mellitus. That December regulatory decision made the drug the first SLGT2 inhibitor approved for any animal. Elanco Animal Health licensed rights to the once-daily flavored tablet last year. The Greenfield, Indiana-based company I will market the product under the name “Bexacat”.

Photo: Waldemarus, Getty Images

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