The ID Pipeline: FDA Activity From the Week of June 9, 2019

Here is a look at infectious disease-related US Food and Drug Administration (FDA) news from the week of June 9, 2019.

Novavax, Inc. to Pursue Global Licensure for RSV Maternal Vaccine

On Monday, June 10, 2019, Novavax, Inc. announced it will pursue global licensure for its respiratory syncytial virus (RSV) maternal vaccine candidate following the Prepare™ Phase 3 clinical trial.

The FDA recommended an additional Phase 3 trial to confirm efficacy of ResVax™ against medically significant RSV in infants born to mothers vaccinated with the candidate.

“We remain encouraged by the ResVax efficacy observed with more severe RSV disease and hospitalizations. These data, coupled with the favorable safety profile of ResVax, demonstrate a positive public health benefit that warrants continued development to address the global unmet medical need in preventing serious RSV disease,” Stanley C. Erck, president and CEO of Novavax, said in a press release. “We aim to identify pathways to licensure that allow pregnant women globally to be vaccinated, so that their babies are protected from the serious short- and long-term consequences of RSV disease.”

Read the full press release here.

Altimmune, Inc. to Move Forward With HepTcell Phase 2 Program After Pre-IND Meeting With FDA

On Monday, June 10, 2019, Altimmune, Inc. announced completion of a pre-Investigational New Drug (IND) meeting with the FDA to discuss its Phase 2 trial design and manufacturing plans for HepTcell, an immunotherapeutic product candidate for chronic Hepatitis B infection.

The FDA did not object to the planned study design and patient populations, as well as plans for manufacturing and product testing, and did not recommend any additional studies in preparation for an IND submission and initiation of Phase 2 trials.

“We are pleased to have completed the pre-IND meeting with the FDA and will move forward with our plans to file the IND and initiate a Phase 2 trial of HepTcell,” Vipin K. Garg, PhD, president and CEO of Altimmune, said in a press release. “We appreciate the FDA’s guidance as we endeavor to find a cure for chronic hepatitis B.”

Read the full press release here.

FDA Grants Breakthrough Device Designation to SpeeDx's ResistancePlus® Diagnostic Test for Gonorrhea

On Tuesday, June 11, 2019, the FDA granted Breakthrough Device Designation to SpeeDx Pty. Ltd. for ResistancePlus® GC, the first commercially available molecular test for predicting ciprofloxacin susceptibility and resistance in the treatment of gonorrhea. The device is already CE-marked and cleared by the Therapeutic Goods Association in Europe, Australia, and New Zealand.

It works by detecting Neisseria gonorrhea and sequencing the gyrA gene of the bacteria associated with susceptibility or resistance to ciprofloxacin.

“We are very pleased that the FDA has recognised ResistancePlus GC as an important tool for the ongoing arms race against gonorrhea and rising antibiotic resistance,” said Colin Denver, SpeeDx CEO. “The results from our tests empower clinicians to make better informed treatment decisions, and we are passionate about the responsible use and stewardship of antibiotics to achieve the best possible patient outcomes.”

Read the full press release here.