Get the latest industry news first when you subscribe to our daily newsletter.
Pharma, BioPharma
By Frank Vinluan
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, used in addition to diet and exercise, as a way to improve the control of blood glucose in adults with type 2 diabetes. Privately held TheracosBio, 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 to 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 a 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

The Covid-19 pandemic has forced life sciences companies to take a fresh look at how they do business. But as they reinvent their operations, companies often overlook a critical function: Their learning and development programs.
Joel Berg

As hospitals face consolidation and CIOs are asked to increase staff productivity, tech companies that can support automation with solutions that are easy to onboard are getting heightened interest.
Stephanie Baum
This article is featured in the Healthcare Docket newsletter, a partnership between Breaking Media publications MedCity News and Above the Law.
Enter your email address to subscribe.
, , , , , ,

When it comes to contacting clinicians and patients, the hospital switchboard can be just as […]
Stephanie Baum
Get the latest industry news first when you subscribe to our newsletter.

As healthcare organizations comply with the federal EPCS mandate, artificial intelligence and digital identity technologies should be utilized to detect, reduce, and remediate drug diversion.
Dan Fabbri, Chief Data Scientist, Imprivata
Our Sites
© 2023 Breaking Media, Inc. All rights reserved. Registration or use of this site constitutes acceptance of our Terms of Service and Privacy Policy.
Privacy Center | Do not sell my information
DMCA compliant image


By admin

Leave a Reply

Your email address will not be published. Required fields are marked *