Shingles vaccine wins approval
FDA approved the herpes zoster vaccine (Shingrix, GlaxoSmithKline) to treat shingles in adults aged 50 years and older.
FDA approved the herpes zoster vaccine (Shingrix, GlaxoSmithKline) to treat shingles in adults aged 50 years and older.
The vaccine contains Agenus Inc.’s proprietary immune adjuvant QS-21 Stimulon, which helps improve the vaccine's effectiveness by boosting immune response in older adults who often experience age-related decline in immunity, according to a statement from Agenus.
Related: Zika vaccine on the horizon
Shingles impacts as many as 1 in 3 older adults over aged 50 years, according to Agenus.
“Beyond shingles, our QS-21 Stimulon is under investigation in numerous vaccines and is a critical component of our neoantigen vaccine formulation, which is currently advancing in a Phase 1 clinical trial in patients with cancer,” said Garo Armen, PhD, chairman and CEO of Agenus, in the statement.
Related: First 4-strain flu vaccine available
FDA approval’s of Shingrix was based on data pooled from two phase 3 clinical trials in more than 37,000 people, which demonstrated an efficacy rate against shingles greater than 90% independent of age, as well as a sustained efficacy over the 4-year follow-up period.
Shingrix also reduced the overall incidence of postherpetic neuralgia (PHN), the most common and often debilitating chronic nerve pain associated with shingles.
The most common side effects reported in clinical trials of Shingrix were pain, redness and swelling at the injection site, the majority of which were transient and mild to moderate in intensity, lasting less than 3 days.
Read next: First US cholera vaccine available
FDA Approves Two More Denosumab Biosimilars, Conexxence and Bomyntra
March 27th 2025The fourth pair of denosumab biosimilars, Conexxence and Bomyntra, are expected to launch in the United States in mid 2025, as a result of a global settlement with Amgen, according to a company news release.
Read More
FDA Approves First Drug for Excess Hunger in Prader-Willi Syndrome
March 27th 2025Vykat XR will be available in April to treat the intense hunger that is a hallmark of the rare genetic disease Prader-Willi syndrome. The price is based on a patient’s weight, and the average patient in the clinical trials would have had an average annual cost of $466,200 for the first year.
Read More
FDA Approves Amvuttra for ATTR-CM in Extended Label
March 21st 2025This expanded indication for Amvuttra makes it the first and only FDA-approved treatment for transthyretin amyloidosis with cardiomyopathy (ATTR-CM) and the polyneuropathy of hereditary transthyretin-mediated amyloidosis (hATTR-PN) in adults.
Read More
