January 30, 2023
Mylan's insulin biosimilar, Semglee, is approved for type-2 diabetes mellitus.
Semglee was approved for treating adults and children with type 2 diabetes mellitus. The drug is developed to demonstrate efficacy versus the reference product, Lantus. Semglee is a long-acting insulin. There is an efficacy demonstration in terms of analytical, non-clinical, and clinical aspects versus Lantus.
January 30, 2023
Alexion's Ultomiris was approved for pediatric patients with paroxysmal nocturnal hemoglobinuria.
Ultomiris (ravulizumab) was approved for treating pediatric patients with paroxysmal nocturnal hemoglobinuria (PNH).
Alexion has received an extension of indication for pediatric patients; previously, it was approved for adult patients with paroxysmal nocturnal hemoglobinuria (PNH).
The approval was based on Phase 3 ALXN210-PNH-304 trial, demonstrating the efficacy and safety of Ultromis in pediatric patients with paroxysmal nocturnal hemoglobinuria (PNH).
The pharmacokinetic and pharmacodynamic studies further demonstrated that weight-based administration of Ultomiris showed inhibition of complete and sustained release of terminal complement, demonstrating an efficacy similar to adults.
January 23, 2022
Dupixent was approved for adults with Prurigo nodularis.
Sanofi's Dupixent (dupilumab) was approved for adults with Prurigo nodularis (PN). Dupixent is indicated with or without topical corticosteroids. It was approved for atopic dermatitis, asthma, and chronic rhinosinusitis with nasal polyps (CRSwNP).
Prurigo nodularis (PN) is a chronic inflammatory skin condition characterized by skin itching for over six weeks. No approved treatments are available for Prurigo nodularis, and topical corticosteroids are used for managing symptoms. However, these therapies are ineffective in treating the disease.
The efficacy was demonstrated in two pivotal studies, demonstrating the efficacy in patients with moderate to severe prurigo nodularis. There was a significant improvement in all measures in PN patients. Dupixent 300 mg every two weeks reduced PN in patients and improved cardinal symptoms.