Cerdelga Approved for the Treatment of Gauchers Diease
August 19, 2014 – Cerdelga (eliglustat) was approved by the Food and Drug Administration (FDA) for the long-term treatment of adult patients with Gauchers Disease Type 1. Manufactured by Genzyme, a Sanofi company, Cerdelga is expected to be available within a month.
Cerdelga is indicated for the treatment of patients who are CYP2D6 extensive metabolizers, intermediate metabolizers or poor metabolizers. An FDA-approved test is administered to determine the level of metabolization as it may not be effective in those who are classified as ultra-rapid metabolizers.
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 a 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.