RSV vaccines for older adults recommended by FDA panel
The FDA's Vaccines and Related Biological Products Advisory Committee voted to recommend the approval of both GSK and Pfizer's respiratory syncytial virus (RSV) vaccine candidates for older adults. The committee found that clinical data support the safety and effectiveness of the vaccines in preventing lower respiratory tract disease caused by RSV in adults age 60 and older.
Clinical trials found the vaccine candidates to be generally well tolerated, with acceptable safety profiles. According to GSK, RSV impacts thousands of older adults in the US each year; those with underlying health conditions, such as respiratory and cardiac diseases and diabetes, are at increased risk of severe complications from RSV.
Only drug approved for prevention of preterm birth exiting US market
Makena (hydroxyprogesterone caproate injection), which the FDA approved more than 12 years ago through its accelerated approval pathway to reduce the risk of preterm birth, is being pulled from the US market by its manufacturer, Covis Pharma, after a second FDA committee recommended withdrawing approval. The committee's vote was based on results from Makena's first confirmatory trial-completion of which is required by the FDA for all drugs that receive accelerated approval-showing that the drug is not effective in reducing the risk of preterm birth, nor does it provide clinical benefit to newborns whose mothers receive it.
Makena's 2011 approval made it the first and only drug indicated for the prevention of preterm birth in the US. In its years on the market, Makena was provided to more than 301,000 women. In 2019, however, following review of the confirmatory trial's results, an FDA advisory panel initially voted to recommend it be pulled from the market. Makena remained available in the interim as the agency's standard process for withdrawing accelerated approval pathway drugs ensued.
FDA approves first bimodal neuromodulation device for tinnitus
The FDA approved Lenire, a bimodal neuromodulation device that is the first of its kind to be greenlit to treat tinnitus. Lenire provides noninvasive sound and tongue electrical stimulation to alleviate symptoms of chronic, subjective tinnitus.
The FDA based the approval on results from the TENT-A3 trial, a study of 112 people with chronic, subjective tinnitus, which sought to determine whether tongue stimulation provided additional benefits over sound-only treatment. The trial showed that, compared with sound therapy alone, participants who were at least moderately affected by tinnitus were more likely to achieve clinically meaningful improvement using bimodal stimulation. No serious adverse reactions were reported. Clinical benefits were achieved in as little as 6 weeks of treatment.
Lenire is a product of Neuromod Devices.
FDA approves migraine nasal spray
The FDA approved Zavzpret (zavegepant) migraine nasal spray, the first and only calcitonin gene-related peptide receptor antagonist nasal spray for the acute treatment of migraine in adults. Zavzpret is a product of Pfizer.
In clinical trials, Zavzpret was shown to be statistically superior to placebo on the coprimary end points of freedom from pain and freedom from the most bothersome symptom at 2 hours postdose. Pain relief was demonstrated as soon as 15 minutes after administration.
As a nasal spray with rapid drug absorption, Zavzpret offers an alternative treatment option for people who need pain relief and cannot take oral medications due to nausea and vomiting. Zavzpret was well tolerated in clinical trials. The most common adverse reactions reported were taste disorders, nausea, nasal discomfort, and vomiting.
Zavzpret is expected to be available in July 2023.