Tecfidera

Generics of Tecfidera not available in Europe until at least 2025

The European Commission (EC) has withdrawn its marketing authorizations for generic versions of Tecfidera (dimethyl fumarate), an oral therapy approved in Europe for relapsing-remitting multiple sclerosis (RRMS). According toĀ Biogen, which developed and markets the brand-name medication, the decision ensures Biogen will have full data and marketing protection…

No Thyroid Problems With DMF Therapy, Records Study Concludes

Treatment with the approved multiple sclerosis (MS) therapy dimethyl fumarate (DMF) did not affect the function of the thyroid gland, an organ that secretes hormones to regulate metabolism, a medical records study concluded. Screening for thyroid problems is not needed for people with MS considered for DMF therapy, the…

Mayzent and Kesimpta Gaining Ground as MS Treatments in Canada

Novartisā€™ Mayzent (siponimod) and Kesimpta (ofatumumab) are gaining ground among multiple sclerosisĀ (MS) therapies in Canada, according to the latest Spherix Global Insightsā€™ report. ā€œFollowing an eventful 2021 that included the launch of two new brands ā€” Novartisā€™ Kesimpta and BMS’ Zeposia ā€” and generic versions of Biogenā€™s…

Vumerity Added to NHS of England for People With Active RRMS

The National Institute for Health and Care Excellence (NICE) has added oralĀ Vumerity (diroximel fumarate), approved to treatĀ relapsing-remitting multiple sclerosisĀ (RRMS) in the U.K., to the list of medications available through the public health program for England. Because the therapy has been recommended through a fast track appraisal process, Vumerity…

#ACTRIMS2022 ā€“ Algorithm Predicts Relapse Risk Using EHR Data

Using a two-step machine learning strategy, researchers have developed an algorithm to predict the risk of multiple sclerosis (MS) relapse based on data gleaned from electronic health records. “The two-step machine learning model predicts a patient’s future one-year MS relapse risk with clinically actionable accuracy, comparable to other clinical…

Vumerity Added to NHS of Scotland for People With Active RMMS

Note: An earlier version of this story stated the Scottish Medicines Consortium approved Vumerity for RRMS patients in that country. The consortium decides to add a medicine to Scotlandā€™s National Health Service; the MHRA approves treatments for England, Scotland, and Wales. The Scottish Medicines Consortium has approved adding the…

Report: Tecfidera, Aubagio Preferred RRMS Treatments in Canada

Tecfidera (dimethyl fumarate) and Aubagio (teriflunomide) are the preferred disease-modifying treatments for managing relapsing-remitting multiple sclerosis (RRMS) in Canada, according to a report from Spherix Global Insights. The report was part of Spherixā€™sĀ RealTime Dynamix: Multiple Sclerosis (Canada) service, which collects data on market trends of MS…

Vumerity Approved for RRMS in European Union

The oral medication Vumerity (diroximel fumarate) has been approved by the European Commission to treat adults with relapsing-remitting multiple sclerosis (RRMS). “This approval is a significant step forward in improving treatment adherence for people living with relapsing MS, which can make a meaningful difference on treatment…

Study Sheds Light on How Tecfidera Kills Immune Cells

The multiple sclerosis (MS) treatment Tecfidera (dimethyl fumarate) triggers immune cell death by interacting with a protein called Keap-1, a new study reveals. The study, “Wdr1 and cofilin are necessary mediators of immune-cell-specific apoptosis triggered by Tecfidera,” was published inĀ Nature Communications. Tecfidera is widely…

Vumerity Recommended for EU Approval as RRMS Treatment

A committee of the European Medicines Agency is recommending that Vumerity (diroximel fumarate) be approved as an oral treatment for adults with relapsing-remitting multiple sclerosisĀ (RRMS) in the European Union. The opinion, from the agency’s Committee for Medicinal Products for Human Use (CHMP), will now be sent…

Safety of Oral DMTs for RRMS in Real-world Use Seen to Match Trial Findings

People with relapsing-remitting multiple sclerosis (RRMS) using approved oral disease-modifyingĀ therapiesĀ generally tolerate the treatments well, with real-world adverse event profiles similar to those seen in clinical trials, an analysis of U.S. data indicates. Results also suggest high adherence to these therapies ā€” meaning patients are usually taking the therapies…

Tecfidera Approved in China to Treat Relapsing MS

Tecfidera (dimethyl fumarate) was given the green light by health regulators in China to treat people withĀ relapsing multiple sclerosis (MS) ā€” clinically isolated syndrome, relapsing-remitting MS, and active secondary progressive MS. The National Medical Products Administration’s (NMPA) decisionĀ came through a priority review of clinical trial data for Tecfidera,…