To start the New Year, the US Food and Drug Administration (FDA) has approved drugs relevant to conditions often treated by nurse practitioners and PAs. Approvals include treatments for schizophrenia and bipolar disorder, pertussis, Alzheimer disease, and type 2 diabetes.
Rykindo® for Schizophrenia and Bipolar Disorder
The FDA has approved Rykindo® (risperidone extended-release injectable suspension for intramuscular [IM] use) to treat schizophrenia in adults, and as monotherapy or as adjunctive therapy to lithium or valproate for the maintenance treatment of bipolar I disorder.
Rykindo is an atypical antipsychotic and is intended for intramuscular injection once every 2 weeks. Approval was based on data from adequate and well-controlled studies with risperidone long-acting injection IM.
Rykindo is supplied as a single-dose kit consisting of a vial, prefilled syringe, clear diluent, vial adapter, and needle. It is available in 12.5 mg, 25 mg, 37.5 mg, and 50 mg dosages.
Adacel® for Use During Pregnancy to Prevent Pertussis in Infants
Adacel® (tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine, adsorbed [Tdap]) was approved by the FDA for immunization during the third trimester to prevent pertussis in infants younger than 2 months.
Approval was based on re-analysis of data obtained from an observational study of the Tdap vaccine. Adacel was estimated to be 88% (95% CI, 43.8-97.4) effective in preventing pertussis in infants younger than 2 months when administered during the third trimester and 14 days before pregnancy. Data from a retrospective passive surveillance study suggest that the rates of major birth defects and miscarriage in women who received Adacel within 30 days prior to pregnancy or during pregnancy are consistent with estimated background rates.
Adacel is administered as a single 0.5-mL intramuscular injection. Adacel should be administered to pregnant individuals during the third trimester and is also indicated for booster immunization against tetanus, diphtheria, and pertussis in individuals 10 to 64 years old.
Leqembi™ for Alzheimer Disease
The FDA has granted accelerated approval to Leqembi™ (lecanemab-irmb) for the treatment of Alzheimer disease. Treatment with Leqembi should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population studied in clinical trials.
Leqembi is a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody directed against aggregated soluble and insoluble forms of amyloid beta. It reduces amyloid beta plaques in the brain.
Accelerated approval was based on a reduction in amyloid beta plaques observed in patients treated with Leqembi. In a phase 2b study, 856 patients with early Alzheimer disease and confirmed amyloid pathology were randomly assigned to receive 1 of 5 doses of Leqembi or placebo (n=247). Patients treated with Leqembi 10 mg/kg every 2 weeks (the approved dose) showed a statistically significant reduction in brain amyloid plaque from baseline to week 79 compared with those who received placebo (difference from placebo, -0.310 [P <.001]).
The most common adverse reactions reported were infusion-related reactions, headache, and amyloid-related imaging abnormalities with edema.
Leqembi is supplied as a preservative-free solution in single-dose vials of 500 mg/ 5 mL and 200 mg/ 2 mL. Treatment is administered by intravenous infusion once every 2 weeks.
Brenzavvy™ for Type 2 Diabetes
The FDA has approved Brenzavvy™ (bexagliflozin), an oral sodium-glucose cotransporter 2 inhibitor, as an adjunct to diet and exercise to improve glycemic control in adults diagnosed with type 2 diabetes.
The approval was based on data from 23 clinical trials that enrolled more than 5000 adults with type 2 diabetes. The efficacy and safety of Brenzavvy were evaluated with the drug used as monotherapy, in combination with metformin, and vs glimepiride and sitagliptin as add-on therapy to metformin. The agent was also studied in adults with type 2 diabetes mellitus with moderate renal impairment, and in adults with type 2 diabetes mellitus with established cardiovascular disease (CVD) or at increased risk for CVD.
Results from these trials indicated that treatment with Brenzavvy significantly reduced hemoglobin A1c compared with placebo. The efficacy of Brenzavvy was observed to be noninferior to glimepiride (titrated to a maximum dose of 6 mg) and sitagliptin 100 mg once daily.
Brenzavvy was not superior to placebo in reducing major adverse cardiovascular events. In a trial that included patients with type 2 diabetes and either established CVD or multiple risk factors for CVD, 10.1% (57/567) of the placebo group experienced 1 reducing major adverse cardiovascular event vs 7.9% (89/1132) of the Brenzavvy group.
The most common adverse reactions reported were female genital mycotic infections, urinary tract infection, and increased urination. Brenzavvyis supplied as 20-mg tablets in 30- and 90-count bottles.
1. Rykindo. Prescribing information. Luye Pharma; 2022. Accessed January 23, 2023. https://www.luye.cn/lvye_en/rykindo.pdf
2. Adacel. Prescribing information. Sanofi Pasteur Inc; 2023. Accessed January 23, 2023. https://www.fda.gov/media/119862/download
3. Leqembi. Prescribing information. Eisai; 2022. Accessed January 23, 2023. https://www.leqembi.com/-/media/Files/Leqembi/Prescribing-Information.pdf
4. Brenzavvy. Prescribing information. TheracosBio; 2022. Accessed January 24, 2023. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/214373s000lbl.pdf