The FDA has approved a sumatriptan iontophoretic transdermal system (Zecuity – Teva) for acute treatment of migraine in adults. Sumatriptan, the first of seven serotonin receptor antagonists (triptans) approved for this indication, is the most frequently prescribed migraine treatment in the US. It is also available in oral, intranasal, and injectable formulations.

The investigational oral antiviral drug molnupiravir (Merck/Ridgeback Biotherapeutics) was granted an FDA Emergency Use Authorization (EUA) on December 23, 2021 for treatment of mild to moderate COVID-19 in outpatients ≥18 years old who are at high risk of progressing to severe disease, including hospitalization or death (see Table 1), and for whom alternative treatment options are not available or clinically appropriate. Paxlovid (Pfizer), nirmatrelvir copackaged with ritonavir, was granted an EUA on December 22, 2021. The IV antiviral drug remdesivir (Veklury) was approved by the...

Erdafitinib (Balversa – Janssen), an oral kinase inhibitor, has received full approval from the FDA for treatment of locally advanced or metastatic urothelial carcinoma in adults with susceptible FGFR3 (fibroblast growth factor receptor) genetic alterations who had disease progression on or after at least one prior line of systemic therapy. It is not recommended for use in patients who are eligible for but have not received prior PD-1 (programmed death receptor-1) or PD-L1 (programmed death-ligand 1) inhibitor therapy. Erdafitinib is the first oral FGFR kinase inhibitor to be...

A new formulation of the H1-antihistamine azelastine hydrochloride 0.1% nasal spray (Astepro - Meda) has been approved by the FDA for treatment of seasonal allergic rhinitis (SAR) in patients ≥12 years old and is being heavily advertised to the public on radio, television and the Internet. All azelastine products require a prescription.

The 2017 adult immunization schedule approved by the CDC's Advisory Committee on Immunization Practices (ACIP) includes some new or revised recommendations.1 The complete schedule is available on the CDC's website (www.cdc.gov/vaccines/schedule). New recommendations for use of influenza vaccine during the 2016-2017 season were included in a previous issue of The Medical Letter.2 Updated recommendations for other vaccines are summarized below. Recommendations for routine use of vaccines in adults were reviewed in an earlier issue.3DK Kim et al. Advisory Committee on Immunization Practices...

Retifanlimab-dlwr (Zynyz – Incyte), a programmed death receptor-1 (PD-1) blocking antibody, has received accelerated approval from the FDA for treatment of metastatic or recurrent locally advanced Merkel cell carcinoma (MCC) in adults. Accelerated approval of the drug was based on the response rate and duration of response. Retifanlimab is the third drug to be approved in the US for treatment of MCC; pembrolizumab (Keytruda), a PD-1 blocking antibody, is approved for the same indication as retifanlimab in patients ≥12 years old and avelumab (Bavencio), a programmed death...

The FDA has approved daridorexant (Quviviq – Idorsia), an orexin receptor antagonist, for treatment of sleep-onset and/or sleep-maintenance insomnia in adults. Daridorexant is the third orexin receptor antagonist to be approved for this indication; suvorexant (Belsomra) and lemborexant (Dayvigo) were approved earlier.

The Immunization Practices Advisory Committee of the US Public Health Service now recommends immunizing all infants and some adolescents against hepatitis B and using a new diphtheria-tetanus-acellular pertussis vaccine (DTaP; ACEL-IMUNE - Lederle) for the fourth and fifth doses of DTP, usually given at 15 to 18 months of age and before school entry (Morbid Mortal Weekly Rep, 40 RR-13:1, November 22, 1991; Morbid Mortal Weekly Rep, 41 RR-1:1, Feb 7, 1992). The Committee on Infectious Diseases of the American Academy of Pediatrics has made similar recommendations but would extend...

The FDA has approved Juluca (ViiV Healthcare/Janssen), a fixed-dose combination of the integrase strand transfer inhibitor (INSTI) dolutegravir (Tivicay) and the non-nucleoside reverse transcriptase inhibitor (NNRTI) rilpivirine (Edurant), as a once-daily complete regimen for treatment of adults with HIV-1 infection who do not have a history of treatment failure or known substitutions associated with resistance to either drug and have been taking a stable suppressive antiretroviral regimen for ≥6 months. Dolutegravir/rilpivirine is the first complete regimen to be approved for...

A patch formulation of the non-ergot dopamine agonist rotigotine (Neupro – UCB) has returned to the US market after a 4-year absence. Originally approved by the FDA in 2007 for treatment of early Parkinson’s disease,1 it was withdrawn in 2008 because of crystallization of the drug in the patch, which could have led to under-dosing. The new patch has somewhat broader indications than the old one; it is approved for use in any stage of Parkinson’s disease (PD) and also for moderate-to-severe restless legs syndrome (RLS).1. Transdermal rotigotine (Neupro) for Parkinson’s disease. Med Lett...