INJECTABLE DRUGS MARKET ANALYSIS

Key Developments

• In March 2024, Regeneron Pharmaceuticals, Inc. announced that the FDA had expanded the approval of Praluent (alirocumab) to include use as an adjunct to diet and other LDL-C-lowering therapies for pediatric patients aged 8 yearsand older with heterozygous familial hypercholesterolemia (HeFH). This approval provides an additional option for children with HeFH whose LDL-C levels remain dangerously high despite existing treatments.
• In November 2023, the USFDA had approved Zepbound (tirzepatide) injection for chronic weight management in adults with obesity or overweight who have at least one weight-related condition. Tirzepatide, already approved as Mounjaro for type 2 diabetes management, is now authorized for use alongside a reduced-calorie diet and increased physical activity. John Sharretts, M.D., highlighted the significance of this approval in addressing the rising rates of obesity and overweight in the U.S., which are linked to major health risks like heart disease, stroke, and diabetes.
• In November 2022, the Food and Drug Administration granted approval for tremelimumab, in combination with durvalumab and platinum-based chemotherapy, for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC)
• In May 2022, the U.S. Food and Drug Administration approved Eli Lilly's Mounjaro (tirzepatide) injection, a new once-weekly dual GIP (glucose-dependent insulinotropic polypeptide) and GLP-1 (glucagon-like peptide-1) receptor agonist. It is designed to enhance glycemic control in adults with type 2 diabetes.