Gilead submits NDA for HIV combination therapy candidate

Gilead Sciences has submitted a new drug application to the FDA for an investigational therapy for the treatment of HIV, according to a press release.

The company’s combination therapy includes two doses of emtricitabine and tenofovir alafenamide (F/TAF), the release said, and is intended for the management of HIV-1 in patients aged 12 years and older. A 200 mg/25 mg-dose is recommended; however, 200 mg/10 mg F/TAF is recommended when combined with a protease inhibitor plus ritonavir or cobicistat.

Compared with Viread (tenofovir disoproxil fumarate, Gilead Sciences; TDF), the nucleotide reverse transcriptase inhibitor TAF showed efficacy and improved renal and bone parameters in phase 3 clinical trials at a dose less than one-tenth of TDF, according to the release.

A 10-mg tablet of TAF was administered with 150 mg elvitegravir, 150 mg cobicistat and 200 mg emtricitabine (E/C/F/TAF) to treatment-naive adults and adolescents, adults with viral suppression and adults with mild-to-moderate renal impairment.

Gilead previously submitted the E/C/F/TAF combination to the FDA in November. An action date is scheduled for Nov. 5; meanwhile, another application for the therapy was submitted to the European Union and confirmed in December.

In bioequivalence studies, the more recent doses of F/TAF submitted to the FDA showed it achieved similar drug levels in the blood compared with E/C/F/TAF, the release said.

“Gilead has a long history of innovating HIV treatments, and with F/TAF we have the potential to further optimize therapies for HIV patients who face a lifetime of antiretroviral treatment,” Norbert Bischofberger, PhD, executive vice president for research and development and chief scientific officer at Gilead Sciences, said in the release.

Other F/TAF-based regimens for the treatment of HIV are being developed through a partnership between Gilead and Janssen Sciences Ireland UC. In addition, Gilead is expected to submit a regulatory application for F/TAF to the European Union later this year, according to the release.

Gilead Sciences has submitted a new drug application to the FDA for an investigational therapy for the treatment of HIV, according to a press release.

The company’s combination therapy includes two doses of emtricitabine and tenofovir alafenamide (F/TAF), the release said, and is intended for the management of HIV-1 in patients aged 12 years and older. A 200 mg/25 mg-dose is recommended; however, 200 mg/10 mg F/TAF is recommended when combined with a protease inhibitor plus ritonavir or cobicistat.

Compared with Viread (tenofovir disoproxil fumarate, Gilead Sciences; TDF), the nucleotide reverse transcriptase inhibitor TAF showed efficacy and improved renal and bone parameters in phase 3 clinical trials at a dose less than one-tenth of TDF, according to the release.

A 10-mg tablet of TAF was administered with 150 mg elvitegravir, 150 mg cobicistat and 200 mg emtricitabine (E/C/F/TAF) to treatment-naive adults and adolescents, adults with viral suppression and adults with mild-to-moderate renal impairment.

Gilead previously submitted the E/C/F/TAF combination to the FDA in November. An action date is scheduled for Nov. 5; meanwhile, another application for the therapy was submitted to the European Union and confirmed in December.

In bioequivalence studies, the more recent doses of F/TAF submitted to the FDA showed it achieved similar drug levels in the blood compared with E/C/F/TAF, the release said.

“Gilead has a long history of innovating HIV treatments, and with F/TAF we have the potential to further optimize therapies for HIV patients who face a lifetime of antiretroviral treatment,” Norbert Bischofberger, PhD, executive vice president for research and development and chief scientific officer at Gilead Sciences, said in the release.

Other F/TAF-based regimens for the treatment of HIV are being developed through a partnership between Gilead and Janssen Sciences Ireland UC. In addition, Gilead is expected to submit a regulatory application for F/TAF to the European Union later this year, according to the release.