The ID Pipeline: FDA Activity From the Week of June 16, 2019

Here is a look at infectious disease-related US Food and Drug Administration (FDA) news from the week of June 16, 2019.

FDA Issues Labeling Revisions for HIV-1 Treatment Biktarvy

On Thursday, June 20, 2019, the FDA has issued labeling revisions for Biktarvy (bictegravir, emtricitabine, and tenofovir alafenamide), a once-daily, single-tablet regimen for the treatment of HIV-1 infection, including an expanded patient population and updated drug interaction data, warnings, and precautions.

Approved by the FDA in February 2018, Gilead Sciences, Inc.’s Biktarvy was initially indicated for adults with HIV-1 with no history of antiretroviral therapy (ART) or as a replacement for a current antiretroviral regimen in adults who achieved virologic suppression (with HIV-1 RNA less than 50 copies per mL) who were on a stable ART regimen for at least 3 months without any history of treatment failure, and with no known substitutions associated with resistance to the individual components of Biktarvy.

The labeling revisions expand the patient population to include HIV-1 infected pediatric patients weighing at least 25 kg.

“The safety of BIKTARVY was evaluated in HIV-1 infected virologically-suppressed subjects between the ages of 12 to less than 18 years and weighing at least 35 kg (N=50) through Week 48 (cohort 1), and in virologically-suppressed subjects between the ages of 6 to less than 12 years and weighing at least 25 kg (N=50) through Week 24 (cohort 2) in an open label clinical trial (Trial 1474),” the FDA reported.

Read more about the FDA's labeling revisions for Biktarvy here.

FDA Signs Off on Prior Approval Supplement for ANI Pharmaceuticals' Vancomycin Hydrochloride for Oral Solution

On Thursday, June 20, 2019, ANI Pharmaceuticals reveived FDA approval of its Prior Approval Supplement for vancomycin hydrochloride for oral solution USP, 250 mg/5 ml for the treatment of various infections.

"Vancomycin for Oral Solution will compete in a current market estimated to exceed $450 million annually, including all drugs indicated for treatment of enterocolitis caused by Staphylococcus aureus (including methicillin-resistant strains) and antibiotic-associated pseudomembranous colitis caused by C difficile," the company said in a statement.

ANI plans to launch the product prior to October 2019.

Read the full press release here.

Bavarian Nordic to Launch Pivotal Phase 3 Trial for Freeze-Dried Formulation of Smallpox Vaccine

On Wednesday, June 19, 2019, Bavarian Nordic announced the initiation of a pivotal phase 3 trial of the freeze-dried formulation of MVA-BN smallpox vaccine.

A total of 1110 healthy, vaccinia-naive subjects will participate in a randomized, double-blind, multicenter trial evaluating the immunogenicity and safety of 3 consecutive vaccine lots of the freeze-dried formulation of the MVA-BN vaccine.

The FDA is currently reviewing the Biologics License Application for the liquid frozen fomulation of MVA-BN, with an expected completion date in the second half of 2019. In 2021, the company plans to submit a supplement to the BLA to extend the approval for both formulations.

“We are excited to initiate this final study which, along with the anticipated approval of the liquid-frozen MVA-BN smallpox vaccine and the completion of our new fill and finish facility later this year, will reinforce our position as the global leader in smallpox vaccines, and also enable us to expand our market opportunities in the US and the rest of the world,” Paul Chaplin, president and CEO of Bavarian Nordic, said in a press release.

Read the full press release here.

FDA Accepts Supplemental NDA for Delafloxacin for Community-Acquired Bacterial Pneumonia

On Wednesday, June 19, 2019, Melinta Therapeutics, Inc., a commercial-stage company focused on the development and commercialization of novel antibiotics to treat serious bacterial infections, announced FDA acceptance of a supplemental New Drug Application (sNDA) for BAXDELA® (delafloxacin) for priority review. The sNDA filing seeks to expand the current indication for BAXDELA to include adult patients with community-acquired bacterial pneumonia (CABP).

The FDA granted priority review status based on the previous Qualified Infectious Disease Product (QIDP) designation, which provides certain incentives for the development of antibacterial and antifungal treatments for serious or life-threatening infections. Through this process, the FDA has assigned a Prescription Drug User Fee Act (PDUFA) action date (proposed review deadline) of October 24, 2019.

"Due to the rise of antibiotic resistance and an aging population, community-acquired bacterial pneumonia, or CABP, remains a challenge for healthcare professionals and has led to a need for new treatment options,” said Sue Cammarata, M.D., chief medical officer of Melinta. "BAXDELA’s potency and activity against the most common bacterial pathogens seen in CABP indicate it could play a significant role in the treatment of this life-threatening illness, if approved. We look forward to working with the FDA to help evaluate bringing this potential option to people with CABP as soon as possible.”

Read the full press release here.

Nabriva Therapeutics Requests Type A Meeting With FDA to Discuss Fosfomycin for Injection (Contepo)

On Wednesday, June 19, 2019, Nabriva Therapeutics announced its submission of a Type A Meeting Request and Briefing Document to the FDA to discuss the Complete Response Letter issued to the company in April for fosfomycin for injection (Contepo).

"As the FDA did not request any new clinical data and did not raise any other concerns with regard to the safety or efficacy of CONTEPO in the CRL, the purpose of the meeting is to discuss and gain clarity on the issues related to facility inspections and manufacturing deficiencies at one of Nabriva’s contract manufacturers that were described in the CRL and other matters pertaining to the steps required for the resubmission of the NDA for CONTEPO," the company said in a press release. "The Type A meeting, per regulation, is required to occur within 30 days of FDA’s receipt of the meeting request."

Read the full press release here.

VBI Vaccines Inc. Announces Positive Top-Line Results From PROTECT Phase 3 Study of Hepatitis B Vaccine

On Monday, June 17, 2019, VBI Vaccines Inc. released positive top-line results from PROTECT, a pivotal phase 3 study evaluating Sci-B-Vac® for hepatitis B.

The randomized, double-blind study sought to analyze the efficacy and safety of a 10 µg dose of Sci-B-Vac®, the company’s trivalent hepatitis B vaccine, compared with a 20 µg dose of the comparator vaccine, Engerix-B®. The study met both of its co-primary endpoints:

• Non-inferiority of seroprotection rate (SPR) of Sci-B-Vac® vs. Engerix-B® in all subjects age ≥ 18 years, 4 weeks after 3rd vaccination (at day 196)
• Superiority of SPR of Sci-B-Vac® vs. Engerix-B® in subjects age ≥ 45 years, 4 weeks after 3rd vaccination (at day 196)

“Hepatitis B is one of the most serious global infectious disease burdens, and successful vaccination of both adults and infants is critical to controlling and, hopefully someday, eradicating the disease,” Timo Vesikari, MD, PhD, director of Vaccine Research Center at the University of Tampere Medical School in Finland, and a principal investigator of the PROTECT and CONSTANT studies, said in a press release. “These results are truly exciting and demonstrate, in a large multicenter controlled trial, the impressive efficacy of Sci-B-Vac® at a dose half that of other hepatitis B vaccines. If approved, this vaccine could play an important role in the prevention of hepatitis B, addressing a significant unmet medical need in the adult population.”

Read the full press release here.