FDA expands indication for Aczone for patients age 9 - 11 with acne
Almirall LLC announced the FDA approval of the expanded indication for Aczone 7.5% (dapsone gel) to include patients aged 9-11. Aczone 7.5% Gel is a prescription medicine used on the skin (topical) to treat inflammatory and non-inflammatory acne, previously approved in February 2016 for patients 12 and older.
The expanded approval was based on data from an open-label safety study to assess safety, pharmacokinetics, and treatment effect of Aczone Gel, 7.5% in 101 patients 9 to 11 years of age with acne vulgaris. Aczone 7.5% Gel was determined to be safe and effective in this patient population.
Related news and insights
Eli Lilly and Company and Incyte announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for Olumiant (baricitinib) for the treatment of adults with severe alopecia areata (AA).
Regeneron Pharmaceuticals, Inc. and Sanofi announced that the FDA has approved Dupixent (dupilumab) 300 mg weekly to treat patients with eosinophilic esophagitis (EoE) aged 12 years and older, weighing at least 40 kg.
Mirati Therapeutics announced that it has submitted a Marketing Authorization Application to the European Medicines Agency for MRTX 849 (adagrasib) for the treatment of patients with non-small cell lung cancer (NSCLC) harboring the KRASG12C mutation who have received at least one prior systemic therapy.