Date: 2016-06-01
Type of information: Granting of a Market Authorisation in the EU
Product name: Odefsey®
Compound: fixed dose combination of rilprivirine, emtricitabine and tenofovir alafenamide available as 25 mg/200 mg/25 mg film-coated tablets
Therapeutic area: Infectious diseases
Action mechanism: reverse transcriptase inhibitor. All three substances act by inhibition of HIV-1 reverse transcriptase, an enzyme needed for replication of the virus; rilpivirine hydrochloride is a non-nucleoside reverse transcriptase. Emtricitabine and tenofovir alafenamide are substrates and competitive inhibitors of HIV reverse transcriptase. After phosphorylation, they are incorporated into the viral DNA chain, resulting in chain termination. Rilprivirine activity is mediated by non-competitive inhibition of HIV 1 reverse transcriptase.
Emtricitabine and tenofovir alafenamide are from Gilead Sciences and rilpivirine is from Janssen Sciences Ireland UC, one of the Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen). The Odefsey® approval is part of an ongoing development and commercialization agreement between Gilead and Janssen, first established in 2009. Under this agreement, Gilead is responsible for the manufacturing, registration, distribution and commercialization of the product in most countries, while Janssen will distribute it in approximately 17 markets and have co-detailing rights in several key markets, including the United States . The original agreement was established for the development and commercialization of Complera®, marketed as Eviplera® in the European Union , and expanded in 2014 to include Odefsey.
Company: Gilead Sciences (USA - CA)
Disease: HIV-1 infection
Latest news:
- • On 28 April 2016, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for Odefsey®,intended for the treatment of adults and adolescents infected with human immunodeficiency virus 1. The benefit with Odefsey® is its ability to achieve an antiretroviral response with a once daily, single pill regimen. The most common side effects are nausea, insomnia and dizziness. The full indication is: "Odefsey® is indicated for the treatment of adults and adolescents (aged 12 years and older with body weight at least 35 kg) infected with human immunodeficiency virus 1 (HIV 1) without known mutations associated with resistance to the non-nucleoside reverse transcriptase inhibitor (NNRTI) class, tenofovir or emtricitabine and with a viral load ? 100,000 HIV 1 RNA copies/mL ." It is proposed that Odefsey® be prescribed by physicians experienced in the management of HIV infection.
- • On March 1, 2016, Gilead Sciences announced that the FDA has approved Odefsey® (emtricitabine 200 mg/rilpivirine 25 mg/tenofovir alafenamide 25 mg or R/F/TAF) for the treatment of HIV-1 infection in certain patients. Odefsey® is Gilead's second TAF-based regimen to receive FDA approval and represents the smallest pill of any single tablet regimen for the treatment of HIV. Odefsey® is indicated as a complete regimen for the treatment of HIV-1 infection in patients 12 years of age and older who have no antiretroviral treatment history and HIV-1 RNA levels less than or equal to 100,000 copies per mL. Odefsey® is also indicated as replacement for a stable antiretroviral regimen in those who are virologically-suppressed (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®. No dosage adjustment of Odefsey® is required in patients with estimated creatinine clearance greater than or equal to 30 mL per minute.
Odefsey has a boxed warning in its product label regarding the risks of lactic acidosis/severe hepatomegaly with steatosis, and post treatment acute exacerbation of hepatitis B. See below for important safety information.
The approval is supported by a bioequivalence study demonstrating that Odefsey® achieved similar drug levels of emtricitabine and TAF in the blood as Genvoya® (elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir alafenamide 10 mg or E/C/F/TAF) and similar drug levels of rilpivirine as Edurant® (rilpivirine 25 mg).
- The safety, efficacy and tolerability of Odefsey® is supported by clinical studies of rilpivirine-based therapy (administered as R+F/TDF or R/F/TDF) and F/TAF-based therapy (administered as E/C/F/TAF) in a range of patients with HIV, including treatment-naïve adults and adolescents, virologically suppressed adults who switched from PI-, NNRTI- and INSTI-based regimens and virologically suppressed adults with mild-to-moderate renal impairment.
Patents:
Submission of marketing authorization application USA :
Submission of marketing authorization application UE:
Withdrawal of marketing authorization application USA:
Withdrawal of marketing authorization application UE:
US authorization: 2016-03-01
UE authorization: 2016-06-01
Favourable opinion UE: 2016-04-28
Favourable opinion USA:
Orphan status USA:
Orphan status UE:
Pediatric exclusivit _USA:
Pediatric exclusivity UE:
OTC status:
Other news:
Is general: Yes
