Recent News and Study Updates in MS Research
By Susan Wells Courtney
Reviewed by Dr. Barry A. Hendin, MSAA Chief Medical Officer
Recently Approved Briumvi™ Now Available for Relapsing Forms of MS
In December, TG Therapeutics announced that the United States Food and Drug Administration (FDA) approved Briumvi™ (ublituximab-xiiy) for the treatment of relapsing forms of multiple sclerosis (MS) in adults – including clinically isolated syndrome, relapsing-remitting MS, and active secondary-progressive MS. This medication is a monoclonal antibody that targets CD20, a protein on the surface of B cells, and induces B-cell depletion within 24 hours. B cells are white blood cells shown to play a role in MS. Briumvi is given by infusion, with two initial doses administered 14 days apart, followed by a one-hour infusion every 24 weeks.
The Phase III ULTIMATE I and ULTIMATE II trials were identical, double-blind, and double-dummy (placebo) studies taking place at 104 sites throughout 10 countries. Enrolled participants were between the ages of 18 and 55, were diagnosed with relapsing MS, were limited to the use and timing of certain disease-modifying treatments, and had an Expanded Disability Status Scale (EDSS) score of 0 to 5.5 (with greater scores indicating more significant disability).
Between September 2017 and October 2018, the ULTIMATE I trial enrolled 549 individuals and the ULTIMATE II trial enrolled 545. Participants were randomized and the numbers were split in half to receive either Briumvi with an oral placebo or Aubagio with an intravenous placebo. The median follow-up of these studies was 95 weeks (a little less than two years) and some of the results were determined through a pooled analysis of both trials.
In studies, Briumvi met its primary end point of reducing annualized relapse rates when compared to individuals taking the oral medication, Aubagio® (teriflunomide). It also met certain secondary endpoints, including the reduction of gadolinium-enhancing lesions as seen on magnetic resonance imaging (MRI), compared to individuals taking Aubagio. Among those taking Briumvi, the most common adverse event was infusion-related reactions (47.7%). Fever, headache, chills, and flu-like symptoms were the most commonly reported symptoms when experiencing an infusion-related reaction.
This new therapy is now available to individuals with MS through their healthcare providers. For more information, please refer to MSAA’s online news item, “FDA approves Briumvi™ for the treatment of relapsing forms of MS” at mymsaa.org; readers may also visit TG Therapeutics’ dedicated patient support website at briumvipatientsupport.com or call 1-833-BRIUMVI (1-833-274-8684).
First Orally Disintegrating Version of Fingolimod Now Available
A new Gilenya® (fingolimod) biosimilar has been approved by the United States Food and Drug Administration (FDA) for relapsing forms of MS and is now available. Marketed under the brand name, Tascenso ODT® (fingolimod), this new formulation is the first and only Gilenya biosimilar to be available in convenient, orally disintegrating tablets.
A biosimilar medication is one that is very similar, but not identical to, the original medication. In order to bring a biosimilar to market, manufacturers need to follow specific guidelines set by the FDA before submitting an application. It must include clinical data showing that the product is of the same efficacy (effectiveness), along with the same safety and purity, as the original biologic, making it “highly similar” to the original, with “no clinically meaningful difference.” This is why the term “biosimilar” is used.
Tascenso ODT® (fingolimod) is an orally disintegrating tablet taken once daily, with or without water or food. It is available in two strengths: 0.25mg and 0.5mg. This formulation dissolves on the tongue within seconds, providing an easy and convenient administration of a DMT. Parent company Cycle Pharmaceuticals Ltd (Cycle) offers an in-house patient-support program called Cycle Vita™. For those who want to initiate or continue treatment with fingolimod, the Cycle Vita program will help to take the place of Gilenya’s patient-support Go Program, which is no longer available to individuals with MS.
Tascenso ODT is specifically indicated for the treatment of relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary-progressive disease, in adults as well as pediatric patients 10 years of age and older. The dose for adults and children weighing more than 88 pounds is 0.5mg daily; children weighing 88 pounds or less receive 0.25mg daily.
As a biosimilar to Gilenya, which was originally FDA-approved in 2010, Tascenso ODT has the same benefits and risks as Gilenya. In studies over the course of two years, individuals taking Gilenya, experienced significant reductions in: relapses; new or enlarging/enhancing lesions; three-month confirmed disability progression; and [reductions in] brain volume loss. Common side effects with Gilenya include headache, flu, diarrhea, back pain, respiratory infections, abnormal liver tests, and cough.
For more information, the Cycle Vita patient-support team may be contacted by calling 1-888-360-VITA (1-888-360-8482) or visiting www.cyclevita.life.