GlaxoSmithKline Pharmaceuticals on Tuesday said it has launched Trelegy Ellipta for Chronic Obstructive Pulmonary Disease (COPD) patients. Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol) is the first once daily single-inhaler triple therapy (SITT) in India for COPD patients.
The European Union’s healthcare regulator the European Medicines Agency (EMA) has decided against a label expansion for GlaxoSmithKline (GSK)’s drug Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol) to include asthma.
GlaxoSmithKline and Innoviva announced the US Food and Drug Administration (FDA) has approved a new indication for Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol ‘FF/UMEC/VI’) for the treatment of asthma in patients aged 18 years and older adding to its current license for use in patients with chronic obstructive pulmonary disease (COPD). Trelegy Ellipta is not indicated for relief of acute bronchospasm.
RadioMedix’s Detectnet (copper Cu 64 dotatate injection) has been approved for the detection of somatostatin receptor‒positive neuroendocrine tumors (NETs) in adult patients during imaging with positron emission tomography.
GlaxoSmithKline has seized the initiative with its three-drug COPD inhaler Trelegy Ellipta despite some new competition from AstraZeneca. To cement its lead, GSK is looking for a first-of-its-kind label update showing Trelegy could cut patients' risk of death—but does the data actually support it?
The FDA on Wednesday said it is requiring a boxed warning and medication guide for Merck’s asthma and allergy drug Singulair (montelukast) and its generics to strengthen existing warnings about the risk of neuropsychiatric events, including suicides, linked to the drug.
GlaxoSmithKline plc (GSK) and Innoviva, Inc. (INVA) today announced the acceptance of a regulatory submission seeking an additional indication for the use of once-daily, single-inhaler triple therapy, Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol or FF/UMEC/VI) for the treatment of asthma in adults by the European Medicines Agency (EMA).
GlaxoSmithKline plc (GSK) and Innoviva, Inc. (INVA) today announced the filing of a supplemental New Drug Application (sNDA) to the US Food and Drug Administration (FDA) seeking an additional indication for the use of once-daily, single-inhaler triple therapy, Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol or FF/UMEC/VI), for the treatment of asthma in adults. Trelegy Ellipta was approved in the US in September 2017 for the treatment of patients with Chronic Obstructive Pulmonary Disease (COPD).
Prospects for AstraZeneca’s respiratory treatments business improved on Wednesday as a three-drug inhaler was shown to ease smoker’s lung and U.S. regulators granted its injectable asthma drug Fasenra special status for a rare lung condition.
As AstraZeneca tussles with British compatriot GlaxoSmithKline in the respiratory arena, it has nabbed its first global approval for Breztri Aerosphere, a three-in-one COPD inhaler that could rival GSK’s Trelegy Ellipta.