The US Food and Drug Administration (FDA) approved several drugs in April 2022 relevant to conditions often treated my nurse practitioners and PAs. Approvals include treatments for topical rosacea, vulvovaginal candidiasis, pediatric urinary tract infections, and cancer.
Zerbaxa® for Pediatric Intra-abdominal, Urinary Tract Infection
The FDA has approved Zerbaxa® (ceftolozane and tazobactam) for the treatment of complicated intra-abdominal infections and complicated urinary tract infections, including pyelonephritis in pediatric patients younger than 18 years of age. Zerbaxa was previously only approved for adults.
Approval was based on data from randomized, active comparator-controlled, double-blind studies that evaluated the safety and tolerability of Zerbaxa. Finding indicated that the safety profile for pediatric patients was similar to those in adults.
The most common adverse reactions reported were thrombocytosis, diarrhea, pyrexia, leukopenia, abdominal pain, vomiting, increased aspartate aminotransferase, and anemia. Zerbaxa is also approved for the treatment of hospital-acquired pneumonia and ventilator-associated bacterial pneumonia in patients 18 years and older. Safety and effectiveness in pediatric patients for this indication have not been established.
VivjoaTM for Vulvovaginal Candidiasis
VivjoaTM (oteseconazole) was approved by the FDA to reduce the incidence of recurrent vulvovaginal candidiasis (RVVC) in “women who are not of reproductive potential,” noted the agency. The approval was based on data obtained from phase 3 trials including 2 global studies that evaluated the safety and efficacy of Vivjoa in patients 12 years of age and older with at least 3 episodes of acute RVVC in the past year.
In one of the studies, 89.7% of patients who received Vivjoa cleared their infection and did not have recurrence during the 50-week maintenance period compared with 57.1% of those who received fluconazole followed by placebo.
The most common adverse reactions reported were headache and nausea. Two recommended dosage regimens were approved: a Vivjoa-only regimen and a fluconazole/Vivjoa regimen.
Epsolay® for Topical Rosacea
The topical cream Epsolay® (benzoyl peroxide) was approved by the FDA for the treatment of inflammatory lesions of rosacea in adults. The medication contains encapsulate benzoyl peroxide 5% within silica-based microcapsules. Once applied, the medication slowly migrates from the microcapsules to deliver an effective dose of benzoyl peroxide to the skin, while also reducing skin irritation.
The approval was based on data from 2 identical, double-blind, phase 3 trials that compared the safety and efficacy of Epsolay in 733 patients with moderate to severe papulopustular rosacea. Results showed that 47.4% and 49.2% of patients in Trials 1 and 2, respectively, reported Investigators Global Assessment (IGA) of 0/1 (treatment success) with Epsolay compared with 20.7% and 28.2% of patients treated with vehicle. At week 12, inflammatory lesions of rosacea were reduced by 68.2% (Trial 1) and 69.4% (Trial 2) with Epsolay vs 38.3% and 46.0%, respectively, with vehicle. In the open-label extension phase (N=547), 73% of Epsolay-treated patients had achieved IGA treatment success at week 52.
The most common side effects reported were application site reactions including pain, erythema, pruritus, and edema.
Alymsys® for Various Cancer Treatments
Alymsys® (bevacizumab-maly), a biosimilar to Avastin® (bevacizumab), was approved by the FDA for treating various cancers.
Alymsys is a vascular endothelial growth factor inhibitor indicated for the treatment of:
- Metastatic colorectal cancer, in combination with intravenous fluorouracil-based chemotherapy for first- or second-line treatment.
- Metastatic colorectal cancer, in combination with fluoropyrimidine-irinotecan- or fluoropyrimidine-oxaliplatin-based chemotherapy for second-line treatment in patients who have progressed on a first-line bevacizumab product-containing regimen.
- Unresectable, locally advanced, recurrent or metastatic nonsquamous non-small cell lung cancer, in combination with carboplatin and paclitaxel for first-line treatment.
- Recurrent glioblastoma in adults.
- Metastatic renal cell carcinoma in combination with interferon alfa.
- Persistent, recurrent, or metastatic cervical cancer, in combination with paclitaxel and cisplatin or paclitaxel and topotecan.
- Epithelial ovarian, fallopian tube, or primary peritoneal cancer, in combination with paclitaxel, pegylated liposomal doxorubicin, or topotecan for platinum-resistant recurrent disease who received no more than 2 prior chemotherapy regimens.
Alymsys is not approved for adjuvant treatment of colon cancer and is supplied in single-dose vials containing 100 mg/4 mL and 400 mg/16 mL.
1. Zerbaxa. Prescribing information. Merck Connect; 2022. Accessed May 10, 2022. https://www.merck.com/product/usa/pi_circulars/z/zerbaxa/zerbaxa_pi.pdf
2. Vivjoa. Prescribing information. Mycovia Pharmaceuticals, Inc.; 2022. Accessed May 10, 2022. http://mycovia.com/wp-content/uploads/2022/04/VIVJOA-Full-Prescribing-Information.pdf
3. Epsolay. Prescribing information. Sol-Gel Technologies Ltd; 2022. Accessed May 10, 2022. https://ml.globenewswire.com/Resource/Download/c90c6cab-73f1-4f49-a08a-83bbf291a415.
4. Alymsys. Prescribing information. Amneal Pharmaceuticals, Inc.; 2022. Accessed May 10, 2022. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761231s000lbl.pdf