GSK submits landmark IMPACT data to US regulatory authority to support expanded label for Trelegy Ellipta

GlaxoSmithKline plc (LSE/NYSE: GSK) and Innoviva, Inc. (NASDAQ: INVA) today announced the filing of a supplemental New Drug Application (sNDA) with the US Food and Drug Administration (FDA) for the use of Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol, 'FF/UMEC/VI') for an expanded indication for the maintenance treatment of airflow obstruction and reduction of exacerbations in patients with chronic obstructive pulmonary disease (COPD).
Source: World Pharma News - Category: Pharmaceuticals Tags: Featured GlaxoSmithKline Business and Industry Source Type: news