The ID Pipeline: FDA Activity From the Week of September 29, 2019

Here is a look at infectious disease-related US Food and Drug Administration (FDA) news from the week of September 29, 2019.

Here is a look at infectious disease-related US Food and Drug Administration (FDA) news from the week of September 29, 2019.

FDA Approves Descovy for HIV PrEP in MSM, Transgender Women

On Thursday, October 3, 2019, the FDA approved emtricitabine 200 mg and tenofovir alafenamide 25 mg (F/TAF; Descovy) for pre-exposure prophylaxis (PrEP) to reduce the risk of HIV infection through sex, excluding those who have receptive vaginal sex. The approval was granted to Gilead Sciences.

F/TAF is not indicated in individuals at risk of HIV infection from receptive vaginal sex because the effectiveness in this population has not been evaluated.

"PrEP drugs are highly effective when taken as indicated in the drug labeling and can prevent HIV infection," said Jeffrey Murray, MD, MPH, deputy director of the Division of Antiviral Products in the FDA's Center for Drug Evaluation and Research in the FDA’s statement. "This approval provides more prevention options for certain patients at-risk for acquiring HIV and helps further efforts by the FDA and the US Department of Health and Human Services to facilitate the development of HIV treatment and prevention options to reduce new HIV infections."

The full story is available here.

FDA Accepts 2 Applications for Merck's Fidaxomicin for C diff

On Wednesday, October 2, 2019, the FDA announced acceptance of a New Drug Application (NDA) and a supplemental NDA submitted by Merck for a Clostridioides difficile treatment for children aged 6 months to 18 years.

The NDA is for Dificid® (fidaxomicin) for oral suspension and the sNDA is for a new indication for use of Dificid® tablets and oral suspension for the treatment of C difficile infections in children aged six months or older. The Prescription Drug User Fee Act (PDUFA), or target action date for both applications, is set for Jan. 24, 2020.

“Evidence indicates the increasing incidence of C difficile-associated diarrhea among hospitalized children,” Nicholas Kartsonis, MD, senior vice president of clinical research, infectious diseases and vaccines at Merck Research Laboratories, said in a press release. “The filings for the pediatric indication for the new investigational oral suspension formulation of DIFICID, as well as for DIFICID tablets, underscore Merck’s focus and dedication to developing infectious disease treatments for those with unmet needs.”

The full press release is available here.

Valneva Announces Completed Recruitment for Phase 2 Studies of Lyme Vaccine Candidate

On Monday, September 30, 2019, Valneva announced it has completed recruitment for the phase 2 studies of its Lyme disease vaccine candidate VLA15.

A total of 819 subjects have been recruited for the 2 ongoing studies, which will support the dose and vaccination schedule to be used in future phase 3 studies.

“We are extremely pleased that all Phase 2 subjects have been recruited as planned and on target," Wolfgang Bender, MD, PhD, chief medical officer of Valneva, said in a press release. "We are making great progress in developing our Lyme disease vaccine candidate with the aim of addressing this significant unmet medical need. I would also like to thank our internal teams as well as our CROs and study sites for their dedication and commitment to achieve the subject recruitment on time. We are looking forward to our initial Phase 2 results in mid 2020.”

The full press release is available here.