New treatment arrival in UK

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Diroximel fumarate is a new treatment used for the treatment of relapsing forms of multiple sclerosis (MS).

Diroximel fumarate was approved for medical use in the United States in October 2019 and has now been approved in the UK and is awaiting final approval by the European Comission in the EU.

Dimethyl fumarate works because it is metabolized to monomethyl fumarate. Diroximel fumarate is a new drug that is also is metabolised to monomethyl fumarate. This too is taken as a twice the day pill (click here for details)

https://www.medicines.org.uk/emc/product/13087/pi

However, in comparison to dimethyl fumarate, diroximel fumarate appears to offer better gastrointestinal tolerability

Naismith RT, Wundes A, Ziemssen T, Jasinska E, Freedman MS, Lembo AJ, Selmaj K, Bidollari I, Chen H, Hanna J, Leigh-Pemberton R, Lopez-Bresnahan M, Lyons J, Miller C, Rezendes D, Wolinsky JS; EVOLVE-MS-2 Study Group. Diroximel Fumarate Demonstrates an Improved Gastrointestinal Tolerability Profile Compared with Dimethyl Fumarate in Patients with Relapsing-Remitting Multiple Sclerosis: Results from the Randomized, Double-Blind, Phase III EVOLVE-MS-2 Study. CNS Drugs. 2020; 34:185-196. 

 DRF 462 mg and DMF 240 mg produce bioequivalent exposure of monomethyl fumarate and are therefore expected to have similar efficacy/safety profiles;

Summaries of Product Characteristics has yet to go on the MH

An SmPC tells healthcare professionals, such as doctors, pharmacists and nurses, how to prescribe and use a medicine correctly. An SmPC is based on clinical trials that a pharmaceutical company has carried out, and gives information about dose, use and possible side effects. An SmPC is always written in a standard format

In the USA this also called the label

diroxymel fumarate US label https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211855s000lbl.pdf

Patient Information Leaflets

A PIL is the leaflet that is included in the pack with a medicine. The PIL is a summary of the SmPC and is written for patients

COI Multiple.

General Disclaimer: Please note that the opinions expressed here are those of the author and do not necessarily reflect the positions of the Barts and The London School of Medicine and Dentistry, nor Barts Health NHS Trust and are not meant to be interpreted as personal clinical advice.  Please note that Professor Gavin Giovannoni has no responsibility for this blog.

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MouseDoctor

1 comment

  • After switching from the starter dose to the regular dose of Tecfidera, blood came out of my mouth and out of my behind!

    This lasted for about 5 days.

    I stopped Tecfidera, while the nurse tried to convince me to keep going on. Yeah right!

    Let’s hope that these pills are indeed better for the gastro…

    Pff

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