Vaccine to prevent Ebola virus disease now approved for use in children
The FDA approved an expanded indication for Ervebo, a vaccine previously approved for the prevention of disease caused by Zaire ebolavirus only in adults, to include use in individuals ages 12 months and older.
Cases of Ebola virus disease are rare in the US; cases that have occurred were in individuals who contracted the disease in other countries before traveling to the US or who were working in healthcare and treating individuals with the infection.
Ervebo is contraindicated in individuals with a history of anaphylaxis to any component of the vaccine, including rice protein. The duration of Ervebo's protection is unknown, and the vaccine does not offer protection against other species of Ebolavirus or Marburgvirus.
Ervebo is a product of Merck.
Treatment for Demodex blepharitis approved
Xdemvy (lotilaner ophthalmic solution) 0.25%, the first treatment expressly for Demodex blepharitis, has been approved by the FDA. Xdemvy targets Demodex mites that invade and reside in hair follicles of the eyelashes and cause eyelid inflammation. Treatment with Xdemvy involves one drop of solution in each eye twice daily over a 6-week course.
Approval was based on the results of two studies that enrolled more than 800 patients. Both studies met the primary endpoint of reducing collarettes (waxy debris of mite waste and eggs) to no more than 2 per upper eyelid by day 43; they also met secondary endpoints of mite eradication and erythema cure.
Xdemvy is a product of Tarsus Pharmaceuticals.
New monoclonal antibody approved to prevent RSV in infants and toddlers
The FDA approved Beyfortus (nirsevimab-alip) for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in neonates and infants born during or entering their first RSV season as well as in children up to age 24 months who are at risk for severe RSV disease development through their second RSV season. Beyfortus is a monoclonal antibody administered as a single I.M. injection prior to or during RSV season.
Ahead of FDA approval, clinical trials showed that a single dose of Beyfortus delivered consistent and sustained efficacy against medically attended RSV lower respiratory tract infection as compared with placebo, with the antibody remaining in the body and providing protection for about 5 months-the typical duration of an RSV season. In trials, Beyfortus was generally well tolerated. Though uncommon, adverse reactions most frequently entailed rash or injection site reactions and mostly qualified as mild or moderate.
Following FDA approval, the Advisory Committee on Immunization Practices (ACIP) issued recommendations regarding the drug. The ACIP recommends one dose of Beyfortus for infants up to 8 months old born during or entering their first RSV season. The ACIP also recommends one dose for infants and children ages 8-19 months at increased risk for severe RSV disease (including children with certain underlying health conditions and American Indian or Alaska Native children) entering their second RSV season. Recommended dosages differ for the two age groups.
Beyfortus is expected to be available ahead of the 2023-2024 RSV season. Beyfortus is a product of AstraZeneca and Sanofi.
First oral treatment for postpartum depression approved
The FDA approved Zurzuvae (zuranolone) for the treatment of postpartum depression (PPD) in adults. Zurzuvae is the first oral medication for treatment of PPD; previously, treatment for PPD was available only as an I.V. injection administered by a healthcare provider. Zurzuvae should be taken once daily in the evening with a fatty meal for 14 days.
Zurzuvae's effectiveness was demonstrated in clinical trials of women with PPD whose symptoms began in the third trimester of pregnancy or within 4 weeks of delivery. Study patients showed significantly more improvement in PPD symptoms with Zurzuvae as compared with those who received placebo. Improvement was maintained at 4 weeks after the last dose of the drug.
Zurzuvae's labeling contains a boxed warning about the medication's impact on ability to drive and perform potentially hazardous activities. It also contains a warning about possible fetal harm.
Zurzuvae is a product of Biogen and Sage Therapeutics.