The U.S. FDA clarifies that multiple sclerosis therapies should be offered to many more people

PRESS RELEASE

FOR IMMEDIATE RELEASE                                                      March 28, 2019

Media inquiries: Daniel Kantor, MD (904)687-7879 or dkantor@MP4MS.com

The U.S. FDA clarifies that multiple sclerosis therapies should be offered to many more people

Coconut Creek, Fl. – The biggest news from the recent approval of the thirteenth branded disease modifying treatment (DMT) for multiple sclerosis (MS) is not that the U.S. Food and Drug Administration (FDA) approved Novartis's Mayzent® (siponimod) as the fourth oral DMT for relapsing forms of MS, but that the FDA finally defined and gave clear guidance on what relapsing forms of MS actually means.

"People living with MS face many potential challenges," according to Dr. Daniel Kantor, Founder and President of the Medical Partnership 4 MS (MP4MS), "but deciphering what Federal regulators mean in densely written package inserts, shouldn't be one of them." As the largest physician and allied healthcare professional organization comprised of those interested in caring for people with MS (as opposed to large MS centers), MP4MS appreciates and congratulates the U.S. FDA for clarifying the definition of relapsing forms of MS. MP4MS accepts no industry financial support. Most of the 13 separate branded DMTs for MS, 2 unbranded generic DMTs for MS and one branded generic DMT for MS share the (until now) unclear indication of "relapsing forms of MS."

"Despite predictions of an indication specifically for secondary progressive forms of MS, Novartis's Mayzent® (siponimod) is FDA-approved for the same indication as most of our other MS DMTs, " said Dr. Samuel F. Hunter, an active member of MP4MS and an MS specialist in Franklin, TN. According to the prescribing information for Mayzent®, it is indicated for "relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults." The FDA's Director of the Division of Neurology Products in the FDA's Center for Drug Evaluation and Research, Billy Dunn, MD, did a great service to the MS community by further clarifying the meaning of "relapsing forms of MS" in the FDA's 03/26/2019 press release by 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."

MP4MS and Neurology Benefit Management, LLC endorse the FDA's statements that support the use of almost all of the currently FDA-approved MS DMTs in patients with relapsing MS (which includes patients ranging from CIS to RRMS to active SPMS). The decision about the timeframe for labeling a patient active vs. non-active SPMS constitutes the Practice of Medicine and so is best left to the clinical decision making of a medical professional knowledgeable in the diagnosis and treatment of MS, and is based on individual clinical, paraclinical and imaging characteristics).

About the Medical Partnership 4 MS (MP4MS):

The Medical Partnership 4 MS (MP4MS) is committed to advocating for multiple sclerosis (MS) patients in the southern United States by engaging the varied stakeholders, and by returning health care to the core values of a strong and united patient-doctor relationship. 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.

About Neurology Benefit Management, LLC

Neurology Benefit Management, LLC increases quality of neurological care and reduces costs by aiding healthcare professionals and payors in the appropriate evidence-based management of patients with neurological conditions.

About Multiple Sclerosis (MS):

Multiple Sclerosis (MS) is the most common acquired disabling neurologic disease of the young. Most people are diagnosed in their twenties to forties, and live life with a relapsing-remitting form of this demyelinating autoimmune disease, and many of them transition to secondary-progressive MS, with disability progression between relapses or even in the absence of relapses.  Newer estimates of the prevalence of MS are that there are close 1,000,000 people living with