FDA approves Incruse Ellipta for treatment of COPD- GSK
GlaxoSmithKline has announced that the FDA has approved Incruse Ellipta (umeclidinium) as an anticholinergic indicated for the long-term, once-daily, maintenance treatment of airflow obstruction in patients with Chronic Obstructive Pulmonary Disease (COPD), including chronic bronchitis and/or emphysema. Umeclidinium is GSK's first once-daily anticholinergic, a type of bronchodilator also known as a long-acting muscarinic antagonist (LAMA), and is contained in the Ellipta inhaler. The FDA-approved strength is 62.5 mcg.
Following this approval by the FDA, it is anticipated that launch activities in the US will commence during the fourth quarter of 2014.
The Respiratory Care Learning Zone contains essential information on Inhaled Therapies in Asthma and COPD and its Management. The Learning Zone also has an Educational Resources section which features slide kits, congress news and webinars and videos relevant to asthma and COPD.
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.