FDA approves novel, dual-targeted treatment for type 2 diabetes mellitus
The FDA approved Mounjaro (tirzepatide) injection to improve blood glucose control in adults with type 2 diabetes mellitus as an addition to diet and exercise. In clinical trials, Mounjaro was shown to be effective at improving blood glucose levels and was more effective than the other diabetes therapies with which it was compared, lowering hemoglobin A1C by 0.5% more than semaglutide, 0.9% more than insulin degludec, and 1% more than insulin glargine.
Mounjaro is a first-in-class medication that activates receptors for both glucagon-like peptide-1 and glucose-dependent insulinotropic polypeptide, hormones involved in control of blood glucose levels. Mounjaro is administered via subcutaneous injection once weekly.
Mounjaro can cause nausea, vomiting, diarrhea, decreased appetite, constipation, upper abdominal discomfort, and abdominal pain. Mounjaro is a product of Eli Lilly and Company.
FDA approves Epsolay topical cream for inflammatory rosacea
The FDA approved Epsolay (benzoyl peroxide) 5% cream for adults with inflammatory lesions of rosacea. Epsolay uses silica-based microcapsules that create a barrier between the skin and the active ingredient. It is designed to slowly release benzoyl peroxide over time to provide a favorable efficacy and safety profile, according to Galderma Laboratories.
The FDA approved Epsolay on the basis of data from two 12-week, phase 3 trials that randomized 733 adults with rosacea to either Epsolay or vehicle cream. Epsolay-treated patients showed an almost 70% reduction in inflammatory lesions from baseline after 12 weeks of treatment, versus 38% to 46% for the group assigned to receive the vehicle without active ingredient.
Epsolay can cause photosensitivity, so patients should be advised to avoid or minimize sun exposure while using the medication.
FDA grants emergency use authorization for Pfizer-BioNTech's COVID-19 booster for children 5 to 11 years old
The US CDC now recommends children ages 5 to 11 years of age should receive a booster shot 5 months after their initial Pfizer-BioNTech vaccination series. "As cases increase across the country, a booster dose will safely help restore and enhance protection against severe disease," the CDC notes. The action was taken after the FDA granted an emergency use authorization for the Pfizer-BioNTech booster in this age group.
Emerging data suggest that vaccine effectiveness against COVID-19 wanes after the second dose of the vaccine in all authorized populations. The FDA has determined that the known and potential benefits of a single booster dose of the Pfizer-BioNTech COVID-19 vaccine for children 5 through 11 years of age is effective in helping to prevent the most severe consequences of COVID-19 in children and older age groups.
FDA approves nonstimulant for adult ADHD
The FDA approved the use of Qelbree (viloxazine extended-release capsules) for adults 18 years of age and older with attention deficit hyperactivity disorder (ADHD). Qelbree was previously approved for children 6 to 17 years of age with ADHD. The selective norepinephrine reuptake inhibitor is the first nonstimulant ADHD option for adults in 20 years.
The medication is available in 100, 150, and 200 mg oral capsules that can be swallowed whole, or the contents can be sprinkled onto certain foods.Qelbree is a product of Supernus Pharmaceuticals.