[Free Report] Gilead Files NDA in Japan for HCV, Plans US, EU Filing for HIV

Gilead announced today it has submitted a New Drug Application (NDA) with Japan’s Pharmaceutical and Medical Devices Agency (PMDA) for approval of a fixed dose combination of NS5A inhibitor ledipasvir and nucleotide analog polymerase inhibitor sofosbuvir for the treatment of patients with genotype 1 HCV.

The NDA is supported by a Japanese Phase 3 study showing 12 weeks of the combo result in 100% SVR12 in both treatment naive and treatment experienced genotype 1 patients, including those with cirrhosis. If approved, this once-daily, all-oral regimen eliminates the need for ribavirin and interferon, simplifying dosing schedules and reducing side-effects.

This filing comes quickly on the heels of a June 27 application with the PMDA for approval of sofosbuvir in combination with ribavirin for the treatment of genotype 2 HCV. Japan is an important market due to its high prevalence of HCV infections. Sofosbuvir is marketed under the trade name Solvaldi; it is not yet approved in Japan.

 

The big biotech is certainly on a roll this year. Earlier in the day, Gilead announced results from 2 pivotal Phase 3 trials in treatment naive patients with HIV comparing a fixed dose regimen containing tenofovir alafenamide (TAF) to one containing tenofovir disoproxil fumarate (tenofovir) met their primary endpoints of non-inferiority.

The studies demonstrated that the single tablet regimen comprising elvitegravir 150 mg, cobicistat 150 mg, emtricitabine 200 mg and TAF 10 mg (E/C/F/TAF), was non-inferior to Gilead’s Stribild® (elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg) based on the proportion of patients with HIV RNA levels (viral load) of less than 50 copies/mL at 48 weeks of therapy. In addition, E/C/F/TAF demonstrated more favorable renal and bone safety compared to Stribild.

Gilead plans on submitting regulatory applications for E/C/F/TAF in the United States and European Union in the fourth quarter of 2014.

Tenofovir has long been the backbone of Gilead’s HIV franchise. As patent expiration nears, shifting patients to the follow-on drug will help protect the company’s dominant position in HIV.

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Author is Long GILD

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