Letter of Appreciation to Billy Dunn, MD of the FDA, regarding defining relapsing forms of MS

Medical Partnership 4 MS 4851 W. Hillsboro Blvd. Suite A-1 Coconut Creek, FL 33073 Tel. (754)444-1195          info@MP4MS.com

March 28, 2019

Billy Dunn, MD

Director, Division of Neurology Products, Office of Drug Evaluation I,

Center for Drug Evaluation and Research (CDER)

U.S. Food and Drug Administration, Building 22, Suite 4346

10903 New Hampshire Avenue, Silver Spring, MD 20993

Re:         Letter of Appreciation regarding defining relapsing forms of MS

Dear Dr. Dunn,

Thank you for helping patients with multiple sclerosis (MS) throughout the United States by clarifying the overall definition of relapsing forms of MS in the prescribing information of Mayzent® (siponimod) and the accompanying FDA press release. The Medical Partnership 4 MS (MP4MS) is committed to advocating for multiple sclerosis (MS) patients throughout the United States by engaging the varied stakeholders. As the largest advocacy group on behalf of providers of MS care, the MP4MS is composed of over 1,300 neurologists and allied health professionals dedicated to the treatment and management of patients with MS, and remains independent by not accepting financial support from the pharmaceutical or insurance industries.

Since most of the MS disease-modifying therapies are indicated for relapsing forms of MS, it has long been a question in the medical and patient community as to what actually constitutes relapsing forms of MS, and in the recent approval of Mayzent® (siponimod) the FDA clarifies that this includes clinically isolated syndrome, relapsing-remitting disease and active secondary progressive disease. Despite the accompanying FDA press release stating that "active SPMS [secondary-progressive MS] is one of the relapsing forms of MS, and drugs approved for the treatment of relapsing forms of MS can be used to treat active SPMS," many patients are denied (or do not seek) care by their physicians and health insurers because it was unclear whether active SPMS was a "relapsing" form of MS.

Again, thank you for your service to the neurological community; please do not hesitate to contact me if MP4MS can be of service to the U.S. FDA. 

Sincerely,

Daniel Kantor, MD, FAAN, FANA
President
Medical Partnership 4 MS (MP4MS)