The FDA has approved dupilumab (Dupixent – Sanofi/Regeneron), a subcutaneously-injected fully human monoclonal antibody, for treatment of adults with moderate to severe atopic dermatitis (eczema) that has not responded to topical therapies. It can be used with or without topical corticosteroids.

The FDA has approved nasal spray formulations of the benzodiazepines diazepam (Valtoco — Neurelis) and midazolam (Nayzilam — UCB) for acute treatment of intermittent episodes of frequent seizure activity (seizure clusters). Diazepam rectal gel (Diastat, Diastat AcuDial, and generics) has been used for this indication for many years.

The FDA has approved Twirla (Agile Therapeutics), a transdermal contraceptive patch containing the estrogen ethinyl estradiol and the progestin levonorgestrel, for use in women with a BMI <30 kg/m². It is the second contraceptive patch to become available in the US; Xulane, a patch that delivers ethinyl estradiol and the progestin norelgestromin, has been available since 2014.

The FDA has approved sacituzumab govitecan-hziy (Trodelvy – Immunomedics), a trophoblast cell-surface antigen-2 (Trop-2)-directed antibody and topoisomerase inhibitor conjugate, for treatment of adults with metastatic triple-negative breast cancer who have received ≥2 prior therapies for metastatic disease. It is the first Trop-2-directed antibody-drug conjugate to become available in the US.

The FDA has approved dasiglucagon (Zegalogue – Zealand) for subcutaneous (SC) treatment of severe hypoglycemia in patients ≥6 years old with diabetes. Dasiglucagon is the third glucagon product to be marketed in the US that does not require reconstitution before administration; Gvoke, a SC formulation approved for use in patients ≥2 years old, and Baqsimi, an intranasal powder approved for use in patients ≥4 years old, have been available since 2019. Injectable glucagon emergency kits (GlucaGen HypoKit, and generics) have been available for years, but they require...

The FDA has approved elacestrant (Orserdu – Stemline), an oral estrogen receptor antagonist, for treatment of estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, estrogen receptor 1 (ESR1)-mutated advanced or metastatic breast cancer in postmenopausal women or men who had disease progression following endocrine therapy. Elacestrant is the first oral selective estrogen receptor degrader (SERD) to be approved for treatment of breast cancer; the injectable SERD fulvestrant (Faslodex, and generics) was approved more than 20 years...

Options in screening for colon cancer include fecal occult blood tests, flexible sigmoidoscopy, colonoscopy, computed tomography (CT) colonography and fecal DNA tests. Since the last Medical Letter article on this subject, more data have become available on colonography.

Modestly elevated C-reactive protein (CRP) concentrations have been associated with an increased risk of coronary heart disease. The recently published and heavily publicized results of the JUPITER trial will lead many patients to ask health care professionals whether they should have a CRP test to see if they should be taking a statin.

Cataracts are the leading cause of blindness worldwide because cataract surgery is not available to most people in developing countries.

The FDA has approved a fixed-dose combination of meropenem, a carbapenem antibiotic, and vaborbactam, a new beta-lactamase inhibitor (Vabomere – Melinta), for IV treatment of adults with complicated urinary tract infections (UTIs) that are proven or strongly suspected to be caused by Escherichia coli, Klebsiella pneumoniae, or Enterobacter cloacae spp. complex. Meropenem (Merrem, and generics) has been approved for years for treatment of complicated skin and skin structure infections, intra-abdominal infections, and bacterial meningitis. Resistance to meropenem and other...