FDA Panel Rejects Neuronix’s NeuroAD Device for Treating Alzheimer’s

Rejected stamp on paper, with pen signing on signature line

While much of the recent attention to Alzheimer’s disease has focused on biopharma and Biogen abandoning much of its aducanumab program, work has been ongoing in the device market for Alzheimer’s disease. Unfortunately, that isn’t making much progress either. A U.S. Food and Drug Administration (FDA) advisory panel voted 14 to 0 against recommending Neuronix’s NeuroAD system for the treatment of mild to moderate Alzheimer’s disease.

Neuronix, based in Yoqneam, Israel, describes neuroAD as a non-invasive medical device to help Alzheimer’s disease patients “achieve sustained cognitive improvement.” The device uses “focused transcranial magnetic stimulation (TMS) to stimulate target areas of the brain responsible for cognitive functions impaired by Alzheimer’s disease,” says Medical Design & Outsourcing. “This stimulation is designed to induce long-term potentiation, which the company said is associated with learning and memory processes, and makes these areas of the brain more receptive to cognitive training. Patients who receive the stimulation simultaneously receive such training.”

The device has been approved for use in Europe, Australia and Israel. The FDA adcom, however, found that the device met FDA safety standards, but the company’s clinical trials didn’t show that it was effective.

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There also seemed to be issued related to the failure on the part of the company to provide specific types of data or follow suggestions the agency made during the trial process.

The FDA application was based on data from a U.S. trial in 130 Alzheimer’s patients who received six weeks of daily treatment with neuroAD and simultaneous cognitive training or sham treatment without cognitive training. The patients’ cognition was then tested at seven weeks and again at 12 weeks, with no treatment after six weeks.

“They did not meet their primary efficacy endpoint and you just can’t get around that,” Mary Jensen, chairwoman of the FDA Neurological Devices Advisory Committee told Medical Design & Outsourcing. “They designed the trial. They came up with what the endpoint would be.”

Neuronix had also supplied the agency with data from other, smaller trials that used a different measurement of cognition. Jensen, also a professor of radiology, neurology and neurological surgery at the University of Virginia in Charlottesville, indicated that this just introduced more uncertainty. The adcom members said it would have been preferable for Neuronix to give patients in the sham arm the same cognitive training as patients in the therapy arm.

In addition, Neuronix did not present postmarket data from patients who had received treatment in other countries.

“The data just didn’t support the application,” Jensen told Medical Design & Outsourcing. “The thing that worries me is that the public looks at this as, ‘Well the FDA didn’t approve it.’ The public really needs to look at it as the sponsor did not make their case because the sponsor had opportunity and input from the FDA all along the way. There were things that the FDA recommended they do and they decided not to, and that’s completely on them. It’s the responsibility of the sponsor to prove that their device is safe and efficacious.”

After the meeting, Eyal Baror, president and chief executive officer of Neuronix stated, “We appreciate the thoughtful consideration of the neuroAD data as well as the needs of the Alzheimer’s disease community of patients and caregivers. We are pleased that the committee recognized the safety of the device, but we are disappointed that the panel’s feedback on our clinical studies and data analysis may result in neuroAD not being available in the U.S. in the foreseeable future. We plan to engage with the FDA to discuss a path forward to ensure that U.S. patients have the same access to this treatment as is enjoyed by Alzheimer’s sufferers in over 30 other countries.”

The FDA is not required to follow the recommendations of their advisory committees, but they usually do, particularly when the recommendation is unanimously against approval. Neuronix is currently running a multi-site clinical trial of the system in the U.S. and Israel.

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