Yonsa Approved to Treat Prostate Cancer
May 22, 2018 – The U.S. FDA has approved Yonsa® (abiraterone acetate), manufactured by Sun Pharma and Churchill Pharmaceuticals, to treat metastatic castration-resistant prostate cancer (mCRPC) when used in conjunction with methylprednisolone.
Yonsa is a novel formulation of abiraterone acetate. It uses proprietary SoluMatrix Fine Particle Technology™ to deliver smaller particles of the active ingredient compared to Janssen Biotech’s similar product, Zytiga® (abiraterone acetate). These smaller particles enable patients to achieve therapeutic levels of the drug in their bodies at half the dose required with Zytiga.
Prescribers should be aware of differences in Yonsa dosing requirements, and take care to avoid potential substitution errors or risks of overdose. Recommended dosing is 500mg of Yonsa once daily, with or without food. Patients should also take 4mg of methylprednisolone twice daily.
Due to its unique formulation, Yonsa is not subject to the patents that protect Zytiga. However, in January 2018, Janssen lost a key Zytiga patent in a ruling delivered by the U.S. Patent Trial and Appeal Board. Generic forms of abiraterone acetate may reach the U.S. market later this year as a result.
Sun Pharma and Churchill Pharmaceuticals have not yet announced launch or pricing plans for Yonsa. The product will be available in 125mg tablets only.
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.