Next Generation Biosimilars
On July 28th, the Food and Drug Administration (FDA) approved Semglee® as the first interchangeable biosimilar insulin product in the United States. Semglee (insulin glargine-yfgn) is indicated to control high blood sugar in adults with Type 2 diabetes and adults and pediatric patients with Type 1 diabetes.
Updated Warning for JAK Inhibitors
On September 1, 2021, the FDA announced required revisions to the Boxed Warning for Xeljanz®/Xeljanz XR® (tofacitinib), Olumiant® (baricitinib), and Rinvoq™ (upadacitnib) to include information about the risks of serious heart-related events, cancer, blood clots, and death.
New Lupus Treatment Approved
On July 30, 2021, the FDA approved SaphneloTM (anifrolumab-fnia) for the treatment of adult patients with moderate to severe systemic lupus erythematosus (SLE) who are receiving standard therapy
Potential New Therapy for Alzheimer's Disease
In July at the Alzheimer’s Association International Conference (AAIC), Lilly shared additional data from TRAILBLAZER-ALZ.
The June 2021 edition of our Clinical Bulletin details advancements in chronic weight management as well as promising results for ulcerative colitis treatment.