Odefsey Approved for HIV
March 1, 2016 – Gilead announced the U.S. Food and Drug Administration’s approval of their drug Odefsey (emtricitabine, rilpivirine, tenofovir alafenamide) for the treatment of HIV-1 infection. It is indicated as a complete regimen for infection in patients 12 years of age and older as an initial therapy in those with no antiretroviral treatment history with HIV-1 RNA less than or equal to 100,000 copies per mL; or to replace a stable antiretroviral regimen in those who are virologically-supressed (HIV-1 RNA less than 50 copies per mL) for at least six months with no history of treatment failure and no known substitutions associated with resistance to the individual components of Odefsey. The recommended dose of Odefsey is one tablet once daily with food, each containing 200mg of emtricitabine, 25mg of rilpivirine, and 25mg of tenofovir alafenamide. Launch for Odefsey was scheduled for March 15, 2016, as a specialty drug containing two HIV nucleoside analog reverse transcriptase inhibitors (NRTIs), emtricitabine, and tenoforvir alafenamide, and rilpivirine, a non-nucleoside reverse transcriptase inhibitor (NNRTI).
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.