Gilead Says European CHMP Adopts Positive Opinion For Its Odefsey For Treating HIV

Gilead Sciences, Inc. GILD disclosed the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMA), adopted a positive opinion on its Marketing Authorization Application (MAA) for Odefsey. The drug with emtricitabine 200 mg/rilpivirine 25 mg/tenofovir alafenamide 25 mg; R/F/TAF was an investigational single tablet regimen for the treatment of HIV-1 infection in adults and adolescents.

According to the company, Odefsey integrated Gilead's emtricitabine and tenofovir alafenamide with rilpivirine, owned by Janssen Sciences Ireland UC, one of the Janssen Pharmaceutical Companies of Johnson & Johnson, and marketed by Janssen Cilag International NV. As far as the European Union was concerned, Odefsey was an investigational product and its efficacy and safety were yet to be established.

The pharmaceutical firm said Odefsey CHMP opinion was part of an ongoing development and commercialization agreement between Gilead and Janssen, first established in 2009. The company added that under this agreement, and pending the product's approval, Gilead would be responsible for the manufacturing, registration, distribution and commercialization of the product in most countries.

On the other hand, Janssen would distribute it in approximately 17 markets and have co-detailing rights in several key markets, including the United States. The company stated that the original agreement was established for the development, as well as, commercialization of Eviplera, marketed as Complera in the United States. It was expanded in 2014 to include Odefsey.