Trelegy Ellipta Receives Expanded Indication
April 24, 2018 – The U.S. FDA has approved an expanded indication for Trelegy™ Ellipta® (fluticasone furoate/umeclidinium/vilanterol) dry powder inhaler, manufactured by GlaxoSmithKline and Innoviva. The product is now indicated to provide maintenance treatment for airway obstruction due to chronic obstructive pulmonary disorder (COPD), as well as to reduce the exacerbation of COPD.
Trelegy Ellipta is the first three-medication combination product to receive FDA approval for maintenance treatment of COPD. The expanded indication allows physicians to prescribe Trelegy Ellipta to a broader base of patients who may need combination therapy for their COPD. The product is not indicated for treatment of acute COPD attacks.
Recommended dosing is one 50mcg inhalation daily. The product carries a black box warning to indicate that it may increase the risk of asthma-related death.
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.