TheracosBio Drug Approval Puts It in Competition With Blockbuster Diabetes Meds

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.


A drug that recently won its first regulatory approval as a way of controlling blood glucose in cats is now approved for treating type 2 diabetes in humans.

The FDA has approved TheracosBio drug bexagliflozin, in addition to diet and exercise, as a way to improve the control of blood glucose in adults with type 2 diabetes. Privately held Theracos, based in Marlborough, Massachusetts, 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 enables the kidneys to absorb glucose. Blocking SGLT2 prevents that absorption, resulting in glucose being excreted in urine. The FDA decision covers only adults 18 and older. In the approval letter sent to the company Friday afternoon, the agency stated it is deferring a decision on the use of the drug in patients ages 10 to 17 because the pediatric study has not been completed.

The FDA nod for Brenzavvy is based on the results of a Phase 3 program that evaluated the drug both as a monotherapy and in addition standard diabetes treatments such as metformin, a first-line diabetes drug. TheracosBio reported that the drug showed a significant reduction in hemoglobin A1c, a measure of blood glucose, after 24 weeks. Clinical trial results also showed “modest decreases” in weight and blood pressure. Similar findings in tests of other diabetes drugs have led pharma companies to seek additional approval in those indications.

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

Brenzavvy will be available as 20 mg tablet, which is a higher dose than the version of bexagliflozin approved by the FDA for treating 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 will market the product under the name “Bexacat.”

Photo: Waldemarus, Getty Images