April 2024 FDA Breakthroughs: Vaccine Approvals, PDUFAs, and More

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FDA-approves mpox vaccine, FDA grants EUA for at-home multiplex papid test, FDA grants PDUFA for GSK 5-in-1 meningococcal vaccine, and more this month from the FDA.

FDA-Approved Mpox Vaccine Now Commercially Available in the US

Jynneos, the FDA-approved vaccine for mpox, is now available for commercial purchase in the United States. Healthcare providers can order the vaccine through wholesalers and distribution partners, making it accessible at pharmacies, physician offices, and public health clinics.

FDA Approves Zevtera for Treatment of Complicated Bacterial Infections

The FDA approved Zevtera (ceftobiprole medocaril sodium for injection), a novel antibiotic treating severe bacterial infections in adults and children. This significant advancement offers hope against Staphylococcus aureus bloodstream infections (SAB), including right-sided infective endocarditis, acute bacterial skin, and skin structure infections (ABSSSI), and community-acquired bacterial pneumonia (CABP) in patients as young as 3 months.

Ceftobiprole Receives FDA Approval, Enhancing Antibiotic Options

Dr. Thomas Holland discusses the breakthrough in antibiotic development. The results were consistent across key subgroups and for secondary outcomes, including mortality rates (9.0% for ceftobiprole and 9.1% for daptomycin; 95% CI, −6.2 to 5.2) and microbiologic eradication rates (82.0% for ceftobiprole and 77.3% for daptomycin; 95% CI, −2.9 to 13.0). Adverse events occurred in 121 out of 191 patients (63.4%) treated with ceftobiprole 117 out of 198 patients (59.1%) treated with daptomycin, with serious adverse events reported in 36 (18.8%), and 45 (22.7%) patients, respectively.

Moderna’s Investigational RSV Vaccine: Preparing for Potential Launch This Year

Last week, Moderna had its fifth annual Vaccines Day. During this day, the company provides updates on its vaccine pipeline. One of the company’s vaccines, its investigational RSV, mRNA-1345, has its PDUFA date in 5 weeks. This vaccine has shown in earlier data that it demonstrated an efficacy of 83.7% against RSV-associated lower respiratory tract disease (RSV-LRTD) as defined by two or more symptoms.

The FDA grants emergency use authorization (EUA) for The CorDx TyFast Flu A/B & COVID-19 At Home Multiplex Rapid Test by CorDx. Designed to differentiate between influenza types A and B and SARS-CoV-2, this test is aimed at individuals experiencing symptoms of respiratory infections like COVID-19 within the first 5 days of symptom onset. Confirmation of results requires at least 2 applications over 3 days, with a mandatory interval of no less than 48 hours between tests.

FDA Approves HIV Therapy for Adolescents

The FDA has approved dolutegravir/lamivudine (Dovato, ViiV Healthcare) for adolescents living with HIV. This therapy becomes the first and only oral, 2-drug, single-tablet regimen available for people aged 12 and older living with HIV.

Pfizer Abrysvo RSV Vaccine Meets Primary Endpoints for Adults Ages 18 to 59

Pfizer announced results from its phase 3 MONeT (RSV IMmunizatiON Study for AdulTs at Higher Risk of Severe Illness, a trial which is evaluating a single dose of its respiratory syncytial virus (RSV) vaccine, RSVPreF3 (Abrysvo), vs placebo in adults 18 to 59 years of age at risk of developing severe RSV-associated lower respiratory tract disease (LRTD).

GSK announced the FDA has accepted for review a Biologics License Application (BLA) for its 5-in-1 meningococcal ABCWY (MenABCWY) vaccine, and the federal agency has provided a PDUFA action date for a decision on February 14, 2025.1 The vaccine combines the antigenic components of its 2 well-established meningococcal vaccines with demonstrated efficacy and safety profiles, Bexsero (Meningococcal Group B Vaccine) and Menveo (Meningococcal [Groups A, C, Y, and W-135] Oligosaccharide Diphtheria CRM197 Conjugate Vaccine). This latest addition to the vaccine family, MenABCWY, will target the 5 groups of the bacteria Neisseria meningitidis (Men A, B, C, W and Y) that cause most invasive meningococcal disease (IMD) cases globally.

Pivmecillinam (Pivya) was given the nod from the federal agency and is indicated for female adults with uncomplicated urinary tract infections (UTIs) caused by susceptible isolates of Escherichia coli, Proteus mirabilis, and Staphylococcus saprophyticus.

The FDA has approved an expanded label update for bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, B/F/TAF (Biktarvy), for pregnant adults with HIV who are virologically suppressed. This expanded label offers patients an alternative regimen for use during pregnancy and for those trying to conceive.

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