A drug that lately gained its first regulatory approval as a means of controlling blood glucose in cats is now accredited for treating kind 2 diabetes in people.
The FDA has accredited TheracosBio drug bexagliflozin, along with weight loss program and train, as a means to enhance the management of blood glucose in adults with kind 2 diabetes. Privately held Theracos, based mostly in Marlborough, Massachusetts, will market its once-daily capsule underneath the title “Brenzavvy.”
Brenzavvy is a small molecule designed to dam sodium-glucose cotransporter 2 (SGLT2), a protein that permits the kidneys to soak up glucose. Blocking SGLT2 prevents that absorption, leading to glucose being excreted in urine. The FDA choice covers solely adults 18 and older. Within the approval letter despatched to the corporate Friday afternoon, the company acknowledged it’s deferring a call on using the drug in sufferers ages 10 to 17 as a result of the pediatric research has not been accomplished.
The FDA nod for Brenzavvy is predicated on the outcomes of a Part 3 program that evaluated the drug each as a monotherapy and along with commonplace diabetes remedies corresponding to metformin, a first-line diabetes drug. TheracosBio reported that the drug confirmed a major discount in hemoglobin A1c, a measure of blood glucose, after 24 weeks. Medical trial outcomes additionally confirmed “modest decreases” in weight and blood strain. Comparable findings in checks of different diabetes medication have led pharma corporations to hunt extra approval in these indications.
The TheracosBio drug joins the category of SGLT2 inhibitors, a few of them of blockbuster merchandise. AstraZeneca reported $3 billion in 2021 gross sales for its SLGT2 inhibitor, Farxiga. Eli Lilly’s gross sales of Jardiance for that yr have been practically $1.5 billion. Johnson & Johnson’s Invokana accounted for $563 million in gross sales in 2021. SLGT2 blocking medication introduce the dangers of probably severe unintended effects. Like different medication within the class, Brenzavvy’s label consists of warnings for ketoacidosis, a complication wherein the blood turns into acidic. Different warnings embrace the next incidence of decrease limb amputations and low blood strain.
Brenzavvy might be accessible as 20 mg pill, which is the next dose than the model of bexagliflozin accredited by the FDA for treating cats with diabetes mellitus. That December regulatory choice made the drug the primary SLGT2 inhibitor accredited for any animal. Elanco Animal Well being licensed rights to the once-daily flavored pill final yr. The Greenfield, Indiana-based firm will market the product underneath the title “Bexacat.”
Photograph: Waldemarus, Getty Photos
