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.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- U.S. Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
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.