FDA gives green light to ANDA for chewable diabetes tablet

Leqselvi (deuruxolitinib) 8 mg tablets are approved for adults with severe alopecia areata, a disease that causes the immune system to attack hair follicles, leading to partial or complete hair loss on the scalp and body.

Kerendia was originally approved in July 2021 to reduce cardiovascular and kidney complications in patients with chronic kidney disease (CKD) associated with type 2 diabetes. This new approval extends its use to a broader patient population.

Orsini will be the specialty pharmacy partner for Ekterly.

According to Regeneron, the drug is a bispecific antibody that binds to B-cell maturation antigen (BCMA) on cancerous plasma cells and CD3 on T cells, directing the immune system to attack and destroy multiple myeloma cells.

Optum Rx officials said they now have eliminated reauthorization requirements for more than 140 chronic disease medications.

A separate Prime analysis, however, of year-over-year claims data for Wegovy and Zepbound only found an improvement in adherence in 2024, suggesting there is an evolving understanding of obesity treatment.