FDA Approves New Treatments for Dermatomyositis and HIV, Expands Mounjaro's Label for Cardiovascular Risk Reduction in Type 2 Diabetes

The U.S. Food and Drug Administration (FDA) has approved several new therapies, significantly expanding treatment options for patients. Priovant's Lisraya (brepocitinib) is now the first targeted oral therapy for adults with dermatomyositis, a rare autoimmune disease. Gilead's Bixlenvo (bictegravir/lenacapavir) received approval as the smallest once-daily single tablet regimen for virologically suppressed adults with HIV. Additionally, the FDA expanded the label for Eli Lilly's Mounjaro (tirzepatide) to include the reduction of major adverse cardiovascular events (MACE), such as cardiovascular death, non-fatal heart attack, or non-fatal stroke, in adults with type 2 diabetes who are at high risk for these events.