MS News that Caught My Eye Last Week: New DMT, Stem Cell Trial, Pediatric MS Treatment Study

FDA Will Review New Drug Application of Diroximel Fumarate for Relapsing Forms of MS

The good news: Another disease-modifying therapy (DMT) has taken a step toward approval in the U.S. The discouraging news: It’s another DMT designed to treat relapsing forms of multiple sclerosis. More than a dozen of those treatments are currently available. When will the pharmaceutical companies focus more on treatments for progressive forms of MS? Only one is approved for primary progressive MS (PPMS) and none are approved for secondary progressive MS (SPMS). Many, if not most, of us eventually develop SPMS. How about it, Big Pharma?

The U.S. Food and Drug Administration (FDA) has agreed to review Alkermes’ request to approve diroximel fumarate (BIIB098) as a treatment for relapsing forms of multiple sclerosis (MS), the company announced.

A final decision by the FDA is expected in the fourth quarter of 2019. If approved, diroximel fumarate likely will be marketed in the U.S. with the brand name Vumerity.

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Cleveland Clinic Chosen for Phase 2 Trial Testing NurOwn Stem Cell Therapy in Progressive MS Patients

This trial is aimed at using stem cells from a patient’s own bone marrow to treat the progressive forms of MS that I mentioned earlier. The trial is very small, with only 20 subjects. But at least it’s moving toward the day when, hopefully, we’ll see stem cell transplants approved as an MS treatment in the U.S.

BrainStorm Cell Therapeutics announced the Cleveland Clinic is the first clinical site contracted in the United States for the Phase 2 multi-center study evaluating the company’s NurOwn mesenchymal stem cell (MSC) therapy in individuals with progressive multiple sclerosis (MS).

“We are very excited to announce The Mellen Center for MS Treatment and Research at Cleveland Clinic as the first contracted U.S. clinical site for this very important Phase 2 progressive MS study that we plan to initiate in early 2019,” Chaim Lebovits, president and CEO of BrainStorm, said in a press release.

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#ACTRIMS2019 – No Evidence of Disease Activity Seen in POMS Adolescents Taking Rituximab, Small Study Shows

Treatments for young people with MS — those 22 and younger — had not been available in the U.S. until last May, when Gilenya (fingolimod) was approved for children at least 10 years old. Now there’s hope that rituximab may also be a useful treatment for MS in pediatric patients.

Data supporting the off-label use of rituximab in adolescents with pediatric-onset multiple sclerosis (POMS) was presented at the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum 2019.

The session, titled “No Evidence of Disease Activity in the Majority of Pediatric-Onset Multiple Sclerosis Patients Receiving Rituximab,” was presented by Nikita Shukla, MD, from the Texas Children’s Hospital/Baylor College of Medicine, on Feb. 28, as part of ACTRIMS’ Poster Session 1.

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