This page uses content from Wikipedia and is licensed under CC BY-SA.

Fluticasone furoate/vilanterol

Fluticasone furoate/vilanterol
Fluticasone furoate and vilanterol.svg
Combination of
Fluticasone furoateCorticosteroid
VilanterolUltra-long-acting β2 agonist
Clinical data
Trade namesBreo Ellipta, Relvar Ellipta
AHFS/Drugs.combreo-ellipta
License data
Pregnancy
category
  • US: C (Risk not ruled out)
Routes of
administration
Inhalation (DPI)
ATC code
Legal status
Legal status
  • US: ℞-only
  • In general: ℞ (Prescription only)

Fluticasone furoate/vilanterol (FF/VI), sold under the trade names Breo Ellipta among others, is a combination medication for the treatment of chronic obstructive pulmonary disease (COPD) and asthma. It contains fluticasone furoate, an inhaled corticosteroid, and vilanterol, an ultra-long-acting β2 agonist (ultra-LABA).

In 2013, the drug was approved for use in the United States by the Food and Drug Administration for long-term maintenance treatment of airflow obstruction in patients with COPD, including chronic bronchitis and emphysema,[1] and the European Medicines Agency approved it as a second-line therapy for the treatment of COPD and asthma.[2]

There are, however, concerns that LABAs such as vilanterol increase the risk of deaths due to asthma.[1]

Medical uses

There is tentative evidence as of 2016 that it is better than placebo for asthma.[3] Evidence is less strong in children.[3]

History

Approval

This drug was approved by the FDA for use as a long-term, once-daily, maintenance treatment in people with COPD in 2013. Labeling changed on April 30, 2015 to add an indication for a once-daily treatment of asthma in people 18 years or older.[4] The exclusivity for a new product ended in May 2016 in the United States, and the exclusivity on the indication for asthma expired on April 30, 2018.[5] The patent for both indications expires on August 3, 2021.[5] The European Medicines Agency approved the drug for marketing on November 13, 2013.[6]

Commercial information

GlaxoSmithKline manufactures this drug. As of December 31, 2015, FF/VI inhalation powder was approved for marketing in 73 countries, and had been launched in 45 countries.[7] Within the trade name, the “Ellipta” is the dry powder inhaler that the medication is administered in. Innoviva developed the active substance vilanterol, and receives royalties on sales.[8]

References

  1. ^ a b "FDA approves Breo Ellipta to treat chronic obstructive pulmonary disease". Food and Drug Administration. 10 May 2013. Archived from the original on 12 January 2017.
  2. ^ "Summary of opinion: Relvar Ellipta" (PDF). European Medicines Agency. 19 September 2013.
  3. ^ a b Dwan, K; Milan, SJ; Bax, L; Walters, N; Powell, C (1 September 2016). "Vilanterol and fluticasone furoate for asthma". The Cochrane Database of Systematic Reviews. 9: CD010758. doi:10.1002/14651858.CD010758.pub2. PMC 6472525. PMID 27582089.
  4. ^ "US Breo Ellipta label" (PDF). FDA. October 2016. Label history is at FDA website page for NDA 204275
  5. ^ a b "Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations". www.accessdata.fda.gov. Retrieved 2016-11-20.
  6. ^ "European Medicines Agency - Find medicine - Relvar Ellipta". www.ema.europa.eu. Retrieved 2016-11-20.
  7. ^ "Innoviva | Primed for Portfolio Growth". www.inva.com. Retrieved 2016-11-20.
  8. ^ "Innoviva Reports Second Quarter 2016 Financial Results | Business Wire". www.businesswire.com. Retrieved 2016-11-20.