PDR Drug Update - May 2025

Bactericidal Newcomer Expands Options for Fighting Uropathogens

More than half of the women in the US acquire a urinary tract infection (UTI) at some point during their lives. It is a common condition that often necessitates prescribing antibiotics such as nitrofurantoin and fosfomycin. Unfortunately, antimicrobial resistance to standard care is increasing, resulting in a loss of effectiveness for existing medications. Accordingly, gaining FDA approval for a medication in a new class of oral antibacterial drugs is a valuable milestone for treating drug-resistant bacteria in uncomplicated UTIs.

The newest addition to the list of drugs approved to treat uncomplicated UTI is Blujepa (gepotidacin). The medication belongs to the class referred to as novel bacterial topoisomerase inhibitors or NBTIs. It is a triazaacenaphthylene antibiotic that works by inhibiting bacterial DNA replication. It is able to block two essential topoisomerase enzymes, DNA gyrase and topoisomerase IV. With a unique mechanism of action providing this dual inhibition, it has the potential to maintain its effectiveness for the long term. The likelihood of bacterial resistance building is reduced since mutations in both of the affected enzymes would be required.

The specific indication for Blujepa is for the treatment of female adult and pediatric patients aged 12 years or older who weigh at least 40 kilograms and have uncomplicated UTIs caused by these specific microorganisms: Escherichia coli, Klebsiella pneumoniae, Citrobacter freundii complex, Staphylococcus saprophyticus, and Enterococcus faecalis. These bacteria are all commonly part of normal human intestinal flora that colonize the skin of the perineum, rectum, urethra, cervix, and gastrointestinal tract. Infection from the organisms can occur when they enter the urethra and travel into the bladder, resulting in cystitis. Unfortunately, multidrug-resistant uropathogens have developed, making them difficult to treat for UTI. E. coli is the most common cause of UTI, so having a new drug that may be less susceptible to resistance allows for more successful treatment outcomes, especially in cases of recurrent UTI.

Side effects associated with the use of Blujepa were reported, including nausea and diarrhea. The prescribing information for Blujepa details specific warnings and precautions for providers to consider before prescribing and to counsel patients regarding, such as QTc prolongation, cholinergic effects, hypersensitivity reactions, and Clostridioides difficile–associated diarrhea. Counsel patients to take Blujepa after a meal to reduce the possibility of gastrointestinal intolerance.

The availability of alternative antibiotics such as Blujepa is a significant development. According to the CDC’s report, Antibiotic Resistance Threats in the United States, 2019, improved antibiotic use is imperative, as the annual number of US individuals with antibiotic resistance reaches approximately 3 million. Accordingly, the label for Blujepa notes in its usage and patient counseling sections that to reduce the development of drug-resistant bacteria and maintain effectiveness, Blujepa should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. Stay informed about advances in long-acting reversible contraception by exploring PDR by ConnectiveRx. You can also stay current by using the official PDR app, mobilePDR, which is available for free from your preferred app store.

FDA New Approvals

Imaavy

The FDA has approved Imaavy (nipocalimab-aahu), a human FcRn-blocking monoclonal antibody, for the treatment of generalized myasthenia gravis. Learn more about Imaavy

Jaythari

The FDA has approved Jaythari (deflazacort) tablets for the treatment of Duchenne muscular dystrophy in patients aged 5 years and older. Learn more about Jaythari

Jobevne

The FDA has approved Jobevne (bevacizumab-nwgd) for intravenous use. Jobevne, a recombinant humanized monoclonal antibody used to treat several different types of cancer, is a biosimilar to the reference product Avastin (bevacizumab). Learn more about Jobevne

Mezofy

The FDA has approved Mezofy (aripiprazole), an oral film-type antipsychotic for schizophrenia that dissolves in the mouth without water. Learn more about Mezofy

Penpulimab-kcqx

The FDA has approved penpulimab-kcqx with cisplatin or carboplatin and gemcitabine for the first-line treatment of adults with recurrent or metastatic non-keratinizing nasopharyngeal carcinoma (NPC). FDA also approved penpulimab-kcqx as a single agent for adults with metastatic non-keratinizing NPC with disease progression on or after platinum-based chemotherapy and at least one other prior line of therapy. Learn more about Penpulimab-kcqx

Qamzova

The FDA has approved Qamzova (meloxicam) injection for use in adults for the management of moderate-to-severe pain, alone or in combination with non-NSAID analgesics. Learn more about Qamzova

Uplizna

The FDA has approved Uplizna (inebilizumab-cdon) as the first and only current treatment for adults living with immunoglobulin G4-related disease. Learn more about Uplizna

Vanrafia

The FDA has approved Vanrafia (atrasentan) for the reduction of proteinuria in adults with primary immunoglobulin A nephropathy at risk of rapid disease progression. Learn more about Vanrafia

Vitrakvi

The FDA has approved Vitrakvi (larotrectinib) for adult and pediatric patients with solid tumors that have a neurotrophic receptor tyrosine kinase gene fusion without a known acquired resistance mutation that have spread or who are not eligible for surgery, and have no satisfactory alternative treatments or that have progressed following treatment, following accelerated approval previously granted in this indication. Learn more about Vitrakvi

Zevaskyn

The FDA has approved Zevaskyn (prademagene zamikeracel) gene-modified cellular sheets, also known as pz-cel, as the first and currently only autologous cell-based gene therapy for the treatment of wounds in adult and pediatric patients with recessive dystrophic epidermolysis bullosa. Learn more about Zevaskyn

FDA New Formulations

Jynneos

The FDA has approved a freeze-dried formulation of Jynneos (smallpox and mpox vaccine, live, non-replicating) for prevention of smallpox and mpox disease in adults aged 18 years and older. This approval will provide additional flexibility for stockpiling against a smallpox event or mpox outbreak. Learn more about Jynneos

Livmarli

The FDA has approved a new tablet formulation of Livmarli (maralixibat) for the treatment of cholestatic pruritus in patients with Alagille syndrome and progressive familial intrahepatic cholestasis. Learn more about Livmarli

FDA New Indications

Dupixent

The FDA has approved Dupixent (dupilumab) for the treatment of adults and adolescents aged 12 years and older with chronic spontaneous urticaria who remain symptomatic despite histamine-1 antihistamine treatment. Learn more about Dupixent

Opdivo plus Yervoy

The FDA has approved Opdivo (nivolumab) plus Yervoy (ipilimumab) as a first-line treatment for adult patients with unresectable or metastatic hepatocellular carcinoma. The agency has also approved Opdivo (nivolumab) plus Yervoy (ipilimumab) as a first-line treatment of adult and pediatric patients aged 12 years and older with unresectable or metastatic microsatellite instability-high or mismatch repair deficient colorectal cancer. Learn more about Opdivo plus Yervoy

FDA New Dosing

Vyvgart Hytrulo

The FDA has approved a new option for patients to self-inject Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) with a prefilled syringe. Vyvgart Hytrulo is for the treatment of adult patients with generalized myasthenia gravis who are anti-acetylcholine receptor antibody positive and adult patients with chronic inflammatory demyelinating polyneuropathy. Learn more about Vyvgart Hytrulo

FDA Recalls

Amneal Ropivacaine HCl

Amneal Pharmaceutical LLC is recalling two lots of ropivacaine HCl injection, USP, 500mg/100mL, infusion bags to the hospital/user level as the products may contain an inert fiber identified as polypropylene fibers from the IV bag. Learn more about the Amneal Ropivacaine HCl recall

Health Fixer Dietary Supplements

Health Fixer is voluntarily recalling all lots of dietary supplements by the name of Male Ultra, Malextra, Electro Buzz, Ultra Armor, and Male Ultra Pro blister packs of 10 capsules per box/carton, to the consumer level. Laboratory analysis has found the products to be tainted with chloropretadalafil, propoxyphenylsildenafil, and sildenafil. Learn more about the Health Fixer Dietary Supplements recall

FDA Alerts

Counterfeit Ozempic

The FDA is warning consumers not to use counterfeit Ozempic (semaglutide) found in the US drug supply chain. The agency advises patients, wholesalers, retail pharmacies, and healthcare professionals to check the Ozempic products they have received and not use, distribute, or sell products labeled with lot number PAR0362 and serial number starting with the first eight digits 51746517. Learn more about the Counterfeit Ozempic recall

May 2025