November 2019 proved to be a fruitful month for urology-specific FDA approvals, with the agency giving the green light to a new drug for complicated urinary tract infection, an implantable device for the treatment of overactive bladder/retention, and a digital product for strengthening of pelvic floor muscles and treatment of urinary incontinence in women.
The FDA approved cefiderocol (FETROJA) in patients 18 years of age or older who have limited or no alternative treatment options, for the treatment of complicated urinary tract infections (cUTI), including pyelonephritis, caused by the following: susceptible Gram-negative microorganisms: Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa, and Enterobacter cloacae complex.
The approval of cefiderocol is based on data from the pivotal APEKS-cUTI study, a multinational, multicenter, double-blind clinical trial that evaluated the drug’s efficacy and safety versus imipenem/cilastatin (IPM/CS) in patients with cUTI, according to a statement from Shionogi & Co., Ltd., the drug’s manufacturer. Study results showed the response rates for the composite endpoint of microbiological eradication and clinical response at the test of cure (TOC) were significantly higher in the cefiderocol arm compared to the IPM/CS arm.
In the study, 72.6% of patients in the cefiderocol arm met the primary endpoint versus 54.6% in the IPM/CS arm at TOC. The adjusted difference between the groups was 18.58% (95% CI: 8.2%, 28.2%). Clinical response rates at the TOC visit were similar between cefiderocol and IPM/CS.
Serious adverse events were reported for 4.7% of patients who received cefiderocol and 8.1% of patients who received IPM/CS.
Shionogi said it anticipates making the drug commercially available in early 2020.
The FDA has also approved the Axonics r-SNM System, an implantable, rechargeable sacral neuromodulation system, for the clinical indications of overactive bladder (OAB) and urinary retention.
Axonics Modulation Technologies, Inc. said the FDA premarket approval grants Axonics the right to market its product in the United States for the indications of OAB (urinary urge incontinence and urinary urge frequency) as well as urinary retention. The approval follows the company’s September 2019 approval for the indication of fecal incontinence.
The FDA approval includes the claim of a 15-year functional life. Axonics said the system also includes a patented tined lead; user-friendly accessories, such as a wireless charging system optimized for infrequent charging; a key-fob patient remote control; and an intuitive clinician programmer that facilitates lead placement and stimulation programming.
FDA approval was supported by results of a detailed review of technical data and the positive results of the Axonics ARTISAN-SNM 129-patient pivotal study that met all primary and secondary endpoints and demonstrated 90% efficacy for all implanted urinary incontinence patients at 6 months, as well as published clinical literature.
The company said the Axonics r-SNM System is the first rechargeable SNM system approved for sale in the U.S., Europe, Canada, and Australia and the only SNM device approved for patients to undergo full-body MRI scan without the necessity of having the device explanted.
In a third urology-related action, the FDA granted 510(k) clearance for the next-generation leva Pelvic Digital Therapeutic for the strengthening of pelvic floor muscles and the treatment of stress, mixed, and mild to moderate urgency urinary incontinence in women.
Renovia Inc. said the leva Digital Therapeutic uses the company’s patented movement-based sensor and app technology to provide women real-time feedback as they perform pelvic floor muscle exercises. The leva Digital Therapeutic is based on the same mechanism of action and sensor technology found in current-generation leva Digital Therapeutic that has been shown to provide statistically significant improvement in objective pelvic floor muscle performance measures, patient-reported urgency incontinence symptom severity, and condition-specific quality of life, the company said.
Renovia recently completed a multicenter, pilot randomized controlled trial using the next-generation leva device. The study included 60 subjects, with the control group performing traditional Kegel exercises. Despite being a 60-subject pilot study, the study found statistically better results among leva users, Renovia reported.
Results of the pilot study are expected in the coming months, and Renovia is using those results to finalize the design of a larger multicenter randomized controlled trial that it will launch in the first half of 2020.