Jan. 23 Quick Takes: TheracosBio’s SGLT2 inhibitor approved for Type II diabetes

After receiving FDA approval in December as Bexacat to treat diabetic cats, the oral SGLT2 inhibitor bexagliflozin is now approved as Brenzavvy to treat people with Type II diabetes. TheracosBio LLC received the approval for human patients, while its partner Elanco Animal Health (NYSE:ELAN) received the approval for cats. The therapy marks at least the fifth SGLT2 inhibitor to reach the U.S. market for Type II diabetes. Farxiga dapagliflozin from AstraZeneca plc (LSE:AZN; NASDAQ:AZN) and Jardiance empagliflozin from Boehringer Ingelheim GmbH and Eli Lilly and Co. (NYSE:LLY) lead the market with blockbuster sales; both were approved in 2014 as adjuncts to diet and exercise for glycemic control in Type II diabetes, as is Brenzavvy. 

FDA’s Peripheral and Central Nervous System Drugs Advisory Committee will meet March 22 to discuss tofersen from Biogen Inc. (NASDAQ:BIIB) and Ionis Pharmaceuticals Inc. (NASDAQ:IONS) for amyotrophic lateral sclerosis (ALS). Tofersen, which has a PDUFA date of April 25, targets SOD1-mutant ALS, a subpopulation that accounts for less than 3% of ALS patients...