Posted from: Tuesday, November 25, 2014 - 03:37 PM - Present

Expanded Olysio Indication Approved

November 5, 2014 – Janssen’s Olysio® (simeprevir) is now FDA-approved for use in combination with Gilead’s Sovaldi® (sofosbuvir) as an all-oral regimen for chronic hepatitis C (CHC) genotype 1 infection in adults.  The recommended dose is 150mg once daily with Sovaldi 400mg once daily for 12 weeks in patients without cirrhosis, or 24 weeks in patients with cirrhosis.

Olysio is a protease inhibitor that was approved on November 22, 2013 for the treatment of CHC genotype 1 infection as a component of a combination antiviral treatment regimen.  Olysio 150mg once daily was initially approved for use with injectable peginterferon-alfa and oral ribavirin for 12 weeks, followed by 12 or 36 additional weeks of peginterferon-alfa and ribavirin depending on prior response status.

Sovaldi is a nucleotide analog polymerase inhibitor that was approved on December 6, 2013 for the treatment of CHC genotypes 1-4 infection as a component of a combination antiviral treatment regimen.  Sovaldi 400mg once daily was approved for use with peginterferon-alfa and ribavirin for 12 weeks for genotypes 1 and 4, and as part of an all-oral regimen with ribavirin for 12 weeks or 24 weeks for genotype 2 and 3, respectively.  This combination regimen is expected to compete with the newly approved Harvoni.

 

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.

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 purposes only.  The reference to any medication above does not imply that the medication is covered by your plan.


Last Updated Monday, July 24, 2017 - 12:00 AM.