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FDA Approves Vivistim System for Chronic Ischemic Stroke
Other FDA approvals include an injection to treat pediatric patients with growth failure and an injection to treat moderate to severe pruritus associated with chronic kidney disease.
FDA recently approved the MicroTransponder Vivistim Paired VNS System (Vivistim System) to treat moderate to severe upper extremity motor deficits associated with chronic ischemic stroke.
Vivistim System is the first-of-its-kind, drug-free rehabilitation system that treats chronic ischemic stroke using vagus nerve stimulation. The system reduces upper limb and extremity motor function deficiencies to improve patients’ ability to move their arms and hands.
“Today’s approval of the Vivistim Paired VNS System offers the first stroke rehabilitation option using vagus nerve stimulation. Used alongside rehabilitative exercise, this device may offer benefit to those who have lost function in their upper limbs due to ischemic stroke,” Christopher M. Loftus, MD, acting director of the FDA’s Center for Devices and Radiological Health’s Office of Neurological and Physical Medicine Devices, said in the announcement.
FDA evaluated the safety and effectiveness of the Vivistim System in a clinical study of 108 patients at 19 clinical sites in the US and UK.
Researchers split patients into a study group and a control group. Both groups completed 300-400 physical therapy exercises for 90 minutes a day for six weeks, three times a week.
In the trial, patients in the treatment group elicited an average score increase of five points, whereas patients in the control group had an average increase of 2.4 points.
Additionally, 47.2 percent of those in the treatment group saw an improvement of six or more points in the FMA-UE score 90 days post-therapy, compared to 23.6 percent in the control group.
The FDA concluded that care providers should use the Vivistim System and post-stroke rehabilitation therapy in both clinical and at-home settings.
FDA OKs Injection to Treat Pediatric Patients with Growth Failure
FDA recently approved Ascenfis Pharma’s once-weekly injection, Skytrofa, to treat pediatric patients with growth failure due to inadequate secretion of endogenous growth hormone.
The agency approved Skytrofa specifically for pediatric patients one year and older who weigh at least 24.5 pounds.
Families can store Skytrofa at room temperature for up to six months. And patients may see 86 percent fewer injection days per year with the once-weekly injection.
Skytrofa is the first product leveraging Ascendis Pharma’s TransCon technology platform, Jan Mikkelsen, president and CEO of Ascendis Pharma, said in the announcement.
Growth hormone deficiency is a severe orphan disease characterized by short stature and metabolic complications. The deficiency halts children’s height, as well as endocrine health and development.
FDA based its approval on results from the Phase 3 heiGHt Trial, which compared Skytrofa to daily somatropin in treatment-native children with growth hormone deficiency.
In the trial, researchers found that Skytrofa elicited a higher AHV at week 52 compared to daily somatropin. Notably, there were no serious adverse events or discontinuations reported.
Ascendis Pharma stated that it will offer a full site of patient support programs, including educating families on proper injection procedures for Skytrofa.
“The approval represents an important new choice for children with GHD and their families, who will now have a once-weekly treatment option,” Paul Thornton, MB BCh, MRCPI, a clinical investigator and pediatric endocrinologist in Texas, said in the announcement.
“This once-weekly treatment could reduce treatment burden and potentially replace the daily somatropin therapies, which have been the standard of care for over 30 years,” Thornton continued.
FDA Approves Injection to Treat Pruritus in Hemodialysis Patients
Vifor Pharma and Cara Therapeutics recently announced that the FDA approved Korsuva injection to treat patients with moderate-to-severe pruritus associated with chronic kidney disease in adults undergoing hemodialysis.
FDA based its approval on the New Drug Application filing supported by positive data from two clinical Phase 3 trials.
“We are very excited about the FDA approval of Korsuva injection,” Abbas Hussain, chief executive officer of Vifor Pharma, said in the announcement.
“There is a significant unmet medical need for a targeted therapy, and we believe that Korsuva injection can fundamentally change the treatment paradigm for adult CKD-aP patients undergoing dialysis. We are committed to bringing this first-in-class medicine to US hemodialysis patients as fast as possible, together with our partner Cara Therapeutics,” Hussain continued.
Vifor Pharma and Cara agreed to an exclusive license to commercialize Korsuva injection in the US.
