Olysio to be Withdrawn from U.S. Market
April 23, 2018 – Janssen Therapeutics has announced that it will withdraw Olysio® (simeprevir) from the United States market due to a decline in sales.
Approved in 2014 for the treatment of hepatitis C, Olysio was the first in a new class of drugs at the time. It has since been outpaced by newer treatments with higher cure rates, including Sovaldi and Harvoni, rendering it obsolete.
Janssen Therapeutics plans to formally conclude marketing efforts for Olysio on May 25, 2018. Patients who are already on Olysio are advised to check with their doctors to ensure they have sufficient supply to complete a full 12-week course of treatment. Supplies of Olysio may not last through May 25th.
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.