The US Food and Drug Administration (FDA) approved several drugs in February 2022 relevant to conditions treated by nurse practitioners and PAs. Approvals include treatments for bacterial vaginosis and trichomoniasis in adolescents, COVID-19, and cold agglutinin disease.
Solosec® for Bacterial Vaginosis and Trichomoniasis in Teens
The FDA has expanded the approval of Solosec® (secnidazole) to include treatment of bacterial vaginosis and trichomoniasis in patients 12 years and older. The approval was based on a multicenter, open-label phase 4 study that evaluated the safety and tolerability of a 2-g single oral dose.
The study consisted of 40 patients (12 to less than 18 years of age) with bacterial vaginosis. Overall safety findings in younger patients were reported to be consistent with findings in adult adult women with trichomoniasis, 4 open-label trials in males with trichomoniasis, and an open-label safety study in adolescent girls with bacterial vaginosis.
Safety and efficacy findings on Solosec in younger patients with trichomoniasis were based on the extrapolation of clinical trial data from adult women with trichomoniasis.
The recommended dosage is a single 2-g packet of granules to be taken once a day. Adverse reactions that occurred in at least 1 patient included nausea and abdominal pain.
Fleqsuvy for Spasticity Due to Multiple Sclerosis
Fleqsuvy (baclofen and suspension) was approved by the FDA for the treatment of spasticity resulting from multiple sclerosis (MS), specifically for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity.
Approval was based on a bioavailability study in healthy adults that compared baclofen tablets with Fleqsuvy.
Fleqsuvy is supplied as a 25 mg/5 mL (5 mg/mL) oral grape-flavored suspension. Fleqsuvy may also be used in patients with spinal cord injuries and other spinal cord diseases.
Bebtelovimab for Mild to Moderate COVID-19
Bebtelovimab has been approved through Emergency Use Authorization by the FDA for treatment of mild to moderate COVID-19 in patients 12 years and older weighing at least 40 kg who are at high risk of developing severe COVID-19 (hospitalization or death).
The emergency approval was based on the safety and efficacy of bebtelovimab from the phase 2 BLAZE-4 trial in patients with mild to moderate COVID-19. The study was conducted prior to the Omicron variant outbreak and no patients in the study were infected with Omicron. However, nonclinical viral neutralization data showed that bebtelovimab retained full neutralizing activity against Omicron and all other known variants of interest and concern, including BA.2.
The most common adverse reactions reported were infusion-related reactions (0.3%), pruritus (0.3%), and rash (0.3%). Treatment may also be associated with hypersensitivity reactions, including anaphylaxis.
Bebtelovimab is administered as a single intravenous injection over at least 30 seconds and is supplied as a 175-mg/2-mL single-dose vial.
Enjaymo™ for Cold Agglutinin Disease
The FDA has approved EnjaymoTM (sutimlimab-jome), a drug that will decrease the need for red blood cell transfusion due to hemolysis in adults with cold agglutinin disease (CAD). Approval was based on data from an open-label, single-arm phase 3 CARDINAL study that evaluated the safety and efficacy of sutimlimab.
The study included 24 patients with primary CAD who recently had a blood transfusion. Patients received the drug through intravenous infusion through week 26. The primary endpoint of the study was the proportion of patients with a response, defined by an increase in hemoglobin (Hgb) of at least 2g/dL from baseline or reaching a Hgb level of at least 12g/dL at the 26-week treatment assessment timepoint, as well as the absence of blood transfusions from weeks 5 to 26 or any other CAD-related treatments.
Results indicated that 54% of patients achieved the composite endpoint, 63% had an increase in HgB level of 2 g/dL or reached an Hgb of at least 12 g/dL. Additionally, 71% (n=17) did not receive RBC transfusion after week 5 and 92% (n=22) did not use other CAD-related treatments. The most common adverse reactions included respiratory tract infection, viral infection, diarrhea, dyspepsia, cough, arthralgia, arthritis, and peripheral edema.
Enjaymo is supplied as an 1100-mg/22-mL single-dose vial and is administered via intravenous infusion.
1. Solosec. Prescribing information. Lupin Pharmaceuticals, Inc; 2021. Accessed February 17, 2022. https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/209363s017lbl.pdf
2. Fleqsuvy. Prescribing information. Azurity Pharmaceuticals; 2022. Accessed February 17, 2022. https://azurity.com/wp-content/uploads/2022/02/FLEQSUVY-PI-02-04-2022.pdf
3. Bebtelovimab. Prescribing information. Eli Lilly and Company; 2022. Accessed February 17, 2022. https://pi.lilly.com/eua/bebtelovimab-eua-factsheet-hcp.pdf
4. Enjaymo. Prescribing information. Sanofi; 2022. Accessed February 17, 2022. https://products.sanofi.us/enjaymo/enjaymo.pdf