A special panel of experts recruited by the Food and Drug Administration Friday narrowly approved a deep brain stimulation device developed by Medtronic Inc. to treat epilepsy.
The panel voted 7-5 to green light the device, which uses electricity to stimulate the anterior nucleus region of the brain. The panel’s findings are not binding on the FDA, but the agency almost always follows its recommendations.
“Epilepsy and its unpredictable seizures can have a major impact on work, school, family life and social functioning, especially for the estimated one-third of individuals who continue to have seizures despite trying a range of treatment options,” Dr. Robert Fisher, a professor of neurology and director of the Stanford Epilepsy Center in Palo Alto, Calif, said in a statement released Saturday by Medtronic.
The close vote reflected some unease with the therapy. On Wednesday, the FDA released documents that said Medtronic failed to demonstrate that patients using the device experienced fewer seizures than patients in the control group who did not receive the therapy.
The agency also noted patients reporting new or worsening anxiety, depression and memory loss were more active in the therapy group than the control group. One patient committed suicide while six others were reported as suicidal. The FDA said three patients died from sudden unexpected death in epilepsy, or 7.6 deaths per 1,000 patients/years.
The FDA panel’s approval comes with conditions: The company must perform a post-approval study for long-term follow-up and labeling requirements.
“We are pleased with the FDA panel’s recommendation today and will work closely with the FDA to address the conditions of approval so that we are able to bring expanded DBS Therapy to market in the United States,” Tom Tefft, senior vice president of Medtronic and president of the Neuromodulation business unit, said in a statement.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
