Posted from: Monday, October 09, 2017 - 05:54 PM - Present

Trelegy Ellipta Approved for COPD

September 18, 2017 – The U.S. FDA has approved Trelegy™ Ellipta®, manufactured by GlaxoSmithKline and Innoviva, for maintenance treatment of chronic obstructive pulmonary disease (COPD). It is the first inhaler approved in the United States to combine three medications for this indication.

Trelegy Ellipta is a dry-powder inhaler, and contains a corticosteroid (fluticasone furoate, 100mcg), a long-acting muscarinic antagonist (umeclidinium, 62.5mcg), and a long-acting beta2-adrenergic agonist (vilanterol, 25mcg). It is intended for patients already taking a fixed-dose combination of fluticasone furoate and vilanterol who require additional bronchodilation to control COPD. Trelegy Ellipta is not intended for treatment of acute bronchospasm or asthma. Recommended dosing is once per day. Trelegy Ellipta carries a black box warning that products containing a beta2-agonist such as vilanterol may increase the risk of death in asthma patients.

Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by U.S. mail or by fax.

Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval.  Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval.  Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.

*This is provided for information only.  The reference to any medication above does not mean the medication is covered by your plan.

Last Updated Friday, November 15, 2019 - 10:41 AM.