The ID Pipeline: FDA Activity From the Week of February 2, 2020

Here is a look at infectious disease-related US Food and Drug Administration (FDA) news from the week of February 2, 2020.

Vemlidy (tenofovir alafenamide) Label Updated

The label for Vemlidy (tenofovir alafenamide) has been updated to include week 48 safety and efficacy data from GS-US-320-4018. The study involves virologically suppressed adults with chronic hepatitis B infection who switched from tenofovir disoproxil fumarate 300 mg once daily to tenofovir alafenamide 25 mg once daily.

Updates to the pregnancy section were also made.

Read the press release.

Preliminary Data from Phase 2 Universal Influenza Vaccine Trial Validates Previous Results

Biondvax Pharmaceuticals announced the publication of preliminary data from the Phase 2 clinical trial of BiondVax’s M-001 universal influenza vaccine candidate. The clinical trial was designed to assess safety and T-cell responses to M-001. The company reports both primary objectives were achieved.

Read the press release.

Phase 3 Clinical Trial of Microbiota Treatment for C Diff Completes Enrollment

Rebiotix has announced that it completed enrollment of a phase 3 clinical trial for RBX2660, an investigational therapy designed to reduce rates of recurrent Clostridioides difficile (C diff) infection.

The treatment is a microbiota based therapy. RBX2660 has previously been granted Fast Track, Orphan, and Breakthrough Therapy Status designations from the FDA.

There are limited options for the treatment of C diff available. The company intends to use results from the trial to apply for FDA licensure.

Read the full article.

FDA to Review Supplemental New Drug Application for Recarbrio (imipenem, cilastatin, relebactam) for Hospital Acquired and Ventilator Associated Bacterial Pneumonia

Merck has announced that the US FDA accepted for review a supplemental New Drug Application for Recarbio. The application has received priority review and a Prescription Drug User Fee Act date of June 4, 2020.

Recarbio is a treatment for adult patients with hospital acquired and ventilator associated bacterial pneumonia caused by Gram-negative microorganisms.

Read the press release.

FDA Issues Emergency Authorization For 2019 Novel Coronavirus Diagnostic

The US FDA issued an emergency use authorization on February 4, 2020, to expand use of a 2019 novel coronavirus (2019-nCoV) diagnostic panel.

The Centers for Disease Control and Prevention’s (CDC) 2019-nCoV Real-Time RT-PCR Diagnostic Panel was previously only authorized for use in CDC laboratories. The new authorization allows use of the test at any CDC qualified lab in the nation.

An emergency use authorization allows an unapproved medical product to be used in an emergency when there are not adequate and available alternatives already approved.

Read the full article.

FDA Approves H5N1 Influenza Vaccine

The US FDA has approved an adjuvanted influenza A H5N1 monovalent vaccine (Audenz). The approval was granted to Seqirus.

The vaccine is approved for individuals 6 months of age or older to protect against influenza A H5N1. The vaccine is the first adjuvanted, cell-based vaccine designed to be used against H5N1 in a potential pandemic scenario.

According to a press release issued by Seqirus, pandemic influenza carries the additional risk of morbidity and mortality because of limited pre-existing immunity to the virus. The new vaccine can be stockpiled for use and is designed to be able to be rapidly deployed.

Read the full article.