The ID Pipeline: FDA Activity From the Week of October 20, 2019

Here is a look at infectious disease-related US Food and Drug Administration (FDA) news from the week of October 20, 2019.

FDA Approves Delafloxacin for Treatment of Community-Acquired Bacterial Pneumonia

On Friday, October 25, 2019, the FDA approved a supplemental new drug application (sNDA) for Melinta Therapeutics' delafloxacin (Baxdela) for the treatment of adults with community-acquired bacterial pneumonia (CABP).

The approval is based on the results of a phase 3 randomized, double-blind study comparing the efficacy and safety of delafloxacin to moxifloxacin. The study results showed that IV-to-oral delafloxacin met the primary end point of statistical non-inferiority for early clinical response (ECR) at 96 hours (± 24 hours) after initiation in the intent-to-treat population with 88.9% ECR in patients who received delafloxacin compared to moxifloxacin (89.0%). Additionally, delafloxacin was generally safe and well-tolerated.

The sNDA follows FDA priority review based on the previous Qualified Infectious Disease Product designation.

The full article is available here.

EU Committee Recommends Marketing Authorizatino for NewLink Genetics' Ebola Vaccine Candidate

On Monday, October 21, 2019, NewLink Genetics Corporation announced the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use returned a positive opinion recommending marketing authorization for its investigational V920 Ebola virus vaccine, rVSV∆G-ZEBOV-GP.

The news follows the recent announcement that the FDA accepted a Biologics License Application (BLA) and granted priority review for the candidate with a Prescription Drug User Fee Act (PDUFA) of March 14, 2020.

“We are delighted by this EMA Committee opinion supporting the conditional marketing authorization of our partnered Ebola virus vaccine,” Carl Langren, chief financial officer and member of NewLink Genetics’ Office of the CEO, said in a statement. “We believe the Committee’s positive opinion represents further recognition of the critical nature of this Ebola outbreak and signifies the urgency with which regulatory bodies are addressing the severe risk this disease poses to a worldwide population.”

The full press release is available here.