The ID Pipeline: FDA Activity From the Week of December 8, 2019

Here is a look at infectious disease-related US Food and Drug Administration (FDA) news from the week of December 8, 2019.

Sulopenem Narrowly Misses Primary End Point in Phase 3 cIAI Study

Interim Therapeutics has announced topline results from a phase 3 trial evaluating sulopenem for the treatment of complicated intra-abdominal infections (cIAIs). According to the new results, the agent “narrowly missed” the primary end point.

Sulopenem is a novel penem anti-infective that has both oral and intravenous formulations. The novel agent has demonstrated in vitro activity against gram-negative, gram-positive and anaerobic bacteria resistant to other antibiotics. The agent was evaluated in the phase 3 Sulopenem for Resistant Enterobacteriaceae (SURE) clinical trial.

The multicenter, double-blind study randomized patients to receive either intravenous sulopenem once daily for at least 5 days followed by oral sulopenem/probenecid twice daily to complete 7-10 total days of treatment, or intravenous ertapenem once daily for at least 5 days followed by oral ciprofloxacin twice daily along with oral metronidazole 4 times daily or, for those patients with ciprofloxacin-resistant organism at baseline, amoxicillin-clavulanate twice daily.

Read the full article here.ViiV Healthcare Files Submissions to the FDA and EMA for Dispersible Formulation of Dolutegravir for Children Living With HIV

ViiV Healthcare has announced regulatory submissions made to both the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA), seeking approval for the first 5mg dispersible tablet formulation of the dolutegravir, as well as a dosing regimen to optimise the use of existing dolutegravir 50mg film coated tablets in pediatric HIV patients.

The submissions to the EMA and FDA are based on data from the ongoing P1093 and ODYSSEY (PENTA20) studies. Data supporting the submissions has been generated from ViiV Healthcare’s collaborations with the U.S. National Institutes of Health and the International Maternal Pediatric Adolescent AIDS Clinical Trials Network for P1093 and the Paediatric European Network for Treatment of AIDS for ODYSSEY.

Read the press release here.