Esbriet Approved for the Treatment of Idiopathic Pulmonary Fibrosis
October 15, 2014 – InterMune received approval from the US Food and Drug Administration (FDA) for Esbriet (pirfenidone) for the treatment of idiopathic pulmonary fibrosis (IPF). Esbriet interferes with the production of Transforming Growth Factor (TGF)-beta, a protein that is involved with inflammation.
Patients should have liver function tests conducted prior to beginning treatment and during treatment with Esbriet. Esbriet is anticipated to be available through limited distribution specialty pharmacies by the beginning of November with a wholesale acquisition cost estimated to be about $9,360 per month for treatment. It is anticipated that a patient would be on this medication for an extended period of time, or until they experience negative side effects which may require temporary dose reduction, treatment interruption or possible discontinuation of therapy.
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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 regular mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular 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. Prices referenced are estimates based on available data and are subject to change at the time a claim is processed. 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.