Blujepa Approved for UTIs
On March 25, 2025, the US Food and Drug Administration (FDA) approved Blujepa™ (gepotidacin – GSK) for the treatment of females 12 years of age and older weighing at least 40 kilograms (kg) with uncomplicated urinary tract infections (uUTIs) caused by the following susceptible microorganisms: Escherichia coli, Klebsiella pneumoniae, Citrobacter freundii complex, Staphylococcus saprophyticus and Enterococcus faecalis. uUTIs are the third-leading cause for outpatient antibiotic prescriptions in adults and children and more than half of all women experience uUTIs at least once in their lifetime. Drug-resistant bacteria are causing more uUTIs leading to higher treatment failure rates. This is a first-in-class oral topoisomerase inhibitor antibiotic that inhibits bacterial DNA replication and provides another treatment, including uUTIs resistant to current antibiotics. One phase III trial showed it was as effective as standard-of-care nitrofurantoin, while another trial, EAGLE-3, demonstrated superiority with 58.5% of participants successful with Blujepa compared to 43.6% with nitrofurantoin. The most common side effects were diarrhea and nausea, which can be reduced by taking Blujepa after a meal. The recommended dose is 1500mg, two 750mg tablets taken orally, twice daily for five days. Blujepa is also in clinical trials for gonorrhea. Cost is not yet known, and launch is planned for the second half of 2025. Here is the prescribing information.
New Formulation for Egrifta
Theratechnologies received FDA approval for Egrifta WR™ (F8 formulation of tesamorelin) for injection to replace Egrifta SV® (F4 formulation of tesamorelin) on March 25, 2025. Egrifta, initially approved in 2010, is a synthetic growth hormone releasing factor analog and remains the only approved medication for the reduction of excess abdominal fat in HIV-infected patients with lipodystrophy. Egrifta WR is a daily injectable like the SV formulation; however, it only needs to be reconstituted once weekly unlike SV, which needs to be reconstituted daily. Egrifta WR also uses less administration volume than the SV formulation. The recommended dose is 1.28mg (0.16mL of the reconstituted solution) injected subcutaneously once daily. It is supplied as single-patient-use vials. Prescribing information can be found here.
Another Indication for Cabometyx
On March 26, 2025, the FDA approved Cabometyx® (cabozantinib – Exelixis) for the treatment of adult and pediatric patients aged 12 years and older with previously treated, unresectable, locally advanced or metastatic, well-differentiated pancreatic neuroendocrine tumors (pNET) and well-differentiated extra-pancreatic neuroendocrine tumors (epNET). Cabometyx interferes with the activity of several receptor tyrosine kinases, proteins that promote the growth and spread of tumors. It is approved for other cancers including renal cell carcinoma, hepatocellular carcinoma, and differentiated thyroid cancer. pNET and epNET cancers tend to be more aggressive with poor prognosis having a five-year survival rate of 23% for advanced disease. The pivotal phase III trial showed statistically significant progression free survival (PFS) in pNET of 13.8 months for cabozantinib versus 4.4 months for placebo and in epNET PFS was 8.4 months versus 3.9 months. In January 2025, the National Comprehensive Cancer Network Clinical (NCCN) Practice Guidelines were updated to include Cabometyx as a preferred regimen for the majority of well-differentiated advanced NET following specific treatments. The recommended dose for those weighing at least 40kg is 60mg orally once daily until disease progression or unacceptable toxicity. Here is revised prescribing information for Cabometyx.
More Denosumab Biosimilars
The FDA approved Fresenius’ biosimilars for Amgen’s receptor activator of nuclear factor kappa beta ligand (RANKL) inhibitor, denosumab, on March 26, 2025. Conexxence® (denosumab-bnht; 60mg/mL prefilled syringe) injection references Prolia® (denosumab), and Bomyntra® (denosumab-bnht; 120mg/1.7mL vial and prefilled syringe) injection references Xgeva® (denosumab). Conexxence is indicated for the treatment of osteoporosis for those at high risk for fracture in certain populations like men, post-menopausal women and those taking glucocorticoids or certain drugs for prostate and breast cancer. It is administered by a healthcare provider as a 60mg subcutaneous (SC) injection once every six months. A boxed warning and a risk evaluation and mitigation strategy (REMS) caution that using Conexxence may raise the risk of dangerous hypocalcemia (low levels of calcium in the blood) for patients who have chronic kidney disease (CKD). Bomyntra is indicated to prevent skeletal-related events for some patients who have multiple myeloma, bone metastases from solid tumors, giant cell tumors of the bone or hypercalcemia of malignancy. After loading doses, it is administered SC at 120mg once every month by a healthcare provider. Jubbonti® (denosumab-bbdz – Sandoz), the first biosimilar to Prolia, and Wyost® (denosumab-bbdz – Sandoz), the first biosimilar to Xgeva, were approved on Mar. 5, 2024; however, due to a settlement agreement cannot launch until May 31, 2025, and will hold interchangeability exclusivity until Oct. 29, 2025. Other biosimilars approved include Ospomyv™ (denosumab-dssb – Samsung Bioepis), and Xbryk™ (denosumab-dssb – Samsung Bioepis) and Stoboclo® (denosumab-bmwo – Celltrion) and Osenvelt® (denosumab-bmwo – Celltrion). Fresnius has reached a settlement agreement with Amgen allowing launch in the US in mid-2025. Prescribing information can be found here.
First FDA Approved Lidocaine 1.8% Generic Patch
On March 26, 2025, the FDA approved the first generic to Scilex Pharmacueticals’ ZTLido® (lidocaine) 1.8% patch. Produced by Aveva Drug Delivery systems, a DifGen company, the generic lidocaine 1.8% patch is a non-opioid topical treatment for post-herpetic neuralgia (PHN) delivering a local dose of lidocaine. Because it uses a different type of patch design, it is bioequivalent to currently available lidocaine patches, such as Lidoderm® (lidocaine) 5% patch. It has a unique adhesive which provides more consistent skin contact. Per IQVIA, annual market sales were $116 million. Prescribing information will be available on the Drugs@FDA drug database at www.fda.gov.
First At Home Chlamydia, Gonorrhea, Trichomoniasis Test Approved
On March 28, 2025, the FDA approved the first at home test for chlamydia, gonorrhea and trichomoniasis that does not require a prescription. The Visby Medical Women’s Sexual Health Test is a single use test that includes a self-collected vaginal swab and testing device, which provides results to the Visby Medical App in about 30 minutes. More information can be found here.
Updated DrugWatch Document Available
The Emerging Therapeutics department has updated DrugWatch, a document that highlights near-term pipeline drugs as well as potential new generic opportunities. The DrugWatch document is attached. It also may be found on OCEP’s SharePoint sites at:
https://esidepartments.express-scripts.com/sites/Dep043/Communications/default.aspx
https://cignatlp.sharepoint.com/sites/OCEP/SitePages/Communications.aspx
Additional Newsflashes Sent This Week
Vykat XR Approved for Hyperphagia in Prader-Willi Syndrome – Thursday, March 27, 2025 Qfitlia Approved for Hemophilia – Friday, March 28, 2025