Prevymis, Vevye, Leqembi, Nirsevimab, Restylane Eyelight

New FDA Approvals

This episode covers the latest FDA approvals from Jun 5 to Jun 9, 2023. Here are the key highlights:

PREVYMIS (letermovir) has been approved by the FDA to prevent cytomegalovirus (CMV) disease in high-risk adult kidney transplant recipients, based on a phase 3 trial where it was found to be superior to valganciclovir in reducing the incidence of CMV disease after kidney transplantation.

Vevye (cyclosporine ophthalmic solution) has received FDA approval as the first waterless cyclosporine-based solution for dry eye disease, showing significant reduction in dry eye disease activity compared to placebo and another cyclosporine product in clinical trials.

An FDA advisory panel has expressed support for traditional US regulatory approval of Leqembi (lecanemab-irmb), a new Alzheimer's drug manufactured by Eisai and Biogen, which has shown promising results in slowing cognitive decline in patients with early Alzheimer's disease. A decision for traditional approval is expected in July.

The FDA's Antimicrobial Drugs Advisory Committee has voted in favor of the safety and efficacy of nirsevimab, a monoclonal antibody, in protecting against respiratory syncytial virus (RSV)-associated lower respiratory disease in infants. Approval decision is anticipated in the third quarter of this year.

Restylane Eyelight, a hyaluronic acid dermal filler manufactured by Galderma, has been FDA-approved for the treatment of undereye hollows in adults over the age of 21, based on positive results from a Phase 3 study evaluating its efficacy and safety in correcting volume loss under the eyes.

Listen to all the episodes here.

Brought to you by Nascentmc.com. A group of MD- and PhD-level medical writers serving the continuing medical education industry and meeting medical writing deadlines with excellence and enthusiasm.

Intro and outro musicGarden Of Love by Pk jazz Collective