The ID Pipeline: FDA Activity from the Week of March 31, 2019

Here is a look at infectious disease related US Food and Drug Administration (FDA) news from the week of March 31, 2019.

Gilead Submits Supplemental NDA for Descovy for PrEP

On Friday, April 5, 2019, Gilead Sciences, Inc. submitted a supplemental new drug application to the US Food and Drug Administration (FDA) for Descovy (emtricitabine 200 mg and tenofovir alafenamide 25 mg tablets) for HIV pre-exposure prophylaxis (PrEP).

The announcement comes a month after Gilead presented data from the phase 3 DISCOVER trial at the Annual Conference on Retroviruses and Opportunistic Infections (CROI 2019). The study found that Descovy was noninferior to Truvada in preventing HIV infection for men and transgender women who have sex with men at high-risk for sexually acquired HIV infection.

“Data have shown that when used in combination with other agents for HIV treatment, Descovy offers high efficacy and additional benefits with respect to renal and bone safety compared with Truvada. Now, the results from the DISCOVER trial suggest that Descovy may offer those same benefits for HIV prevention, which are important considerations for the potential long-term use of PrEP,” John McHutchison, AO, MD, chief scientific officer and head of Research and Development at Gilead, said in a company statement. “We look forward to working with the FDA to help evaluate bringing this option to people at risk of acquiring HIV infection.”

Descovy is approved in the United States for use in combination with other antiretroviral agents for the treatment of HIV-1 infection in patients weighing at least 35 kg, but it does not currently include a PrEP indication.

A priority review voucher was submitted with the filing. The anticipated review time is 6 months.

The full press release is available here.

Entasis Therapeutics Launches Global Phase 3 Trial of ETX2514SUL for Infections Caused by Carbapenem-Resistant Acinetobacter

On Thursday, April 4, 2019, Entasis Therapeutics announced the launch of the ATTACK phase 3 pivotal clinical trial to evaluate ETX2514SUL, a fixed-dose combination of its broad-spectrum β-lactamase inhibitor ETX2514 with sulbactam. ETX2514SUL is used to treat patients with penumonia and bloodstream infections caused by carbapenem-resistant Acinetobacter baumannii, which currently has very limited therapeutic options because of its multidrug resistance.

The 2-part trial (Acinetobacter Treatment Trial Against Colistin) will enroll a total of 300 patients from 18 countries, and Entasis is optimistic that results will be sufficient to support the filing of a new drug application with regulatory authorities in both the US and Europe.

"We are excited to initiate our global ATTACK clinical trial with the ultimate goal of obtaining regulatory approval in the US and other countries,” Manos Perros, CEO of Entasis Therapeutics, said in a company statement. “It is the culmination of extensive preclinical development and multiple Phase 1 and 2 clinical trials, which have shown that ETX2514SUL has great potential for the treatment of patients with carbapenem-resistant A baumannii infections. We are fully funded through this study and look forward to reporting top-line data in the second half of 2020.”

ETX2514SUL has been granted a Qualified Infectious Disease Product and Fast Track designation by the US Food and Drug Administration.

The full press release is available here.