Elelyso Approved for Pediatric Use
August 28, 2014 – The Food and Drug Administration (FDA) extended the approval of Elelyso (taliglucerase alfa) for patients with Gaucher Disease who are as young as four years old. Elelyso is manufactured by Pfizer and Protalix BioTherapeutics and was originally approved for adults with type 1 Gaucher Disease in May of 2012.
Elelyso is administered every two weeks through intravenous infusion to replace an enzyme that is missing in patients with the hereditary condition. Proper maintenance helps prevent blood, bone, joint and nerve problems that can result from the fat build up in the blood cells due to the missing enzyme if the disease is not treated.
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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 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.