See the DrugPatentWatch profile for Vumerity
Vumerity, a medication for relapsing forms of multiple sclerosis (MS), received FDA approval on October 22, 2019 [1]. The drug is manufactured by Biogen [2].
What is Vumerity used for?
Vumerity is approved for the treatment of adults with relapsing forms of multiple sclerosis [1]. This includes conditions like clinically isolated syndrome, relapsing-remitting MS, and active secondary progressive MS [3].
How does Vumerity work?
Vumerity, also known by its generic name diroximel fumarate, is a fumaric acid ester [4]. It works by reducing inflammation and protecting nerve cells from damage, which are key aspects of MS progression [4][5]. Diroximel fumarate is designed to be converted into monomethyl fumarate (MMF) in the body, the active metabolite of dimethyl fumarate (DMF), but with a potentially different gastrointestinal tolerability profile [4][6].
What is the difference between Vumerity and Tecfidera?
Both Vumerity (diroximel fumarate) and Tecfidera (dimethyl fumarate) are fumaric acid esters used to treat relapsing forms of MS [4][7]. They are both converted to the active metabolite monomethyl fumarate (MMF) in the body [4][7]. However, Vumerity was developed with the aim of improving gastrointestinal tolerability compared to Tecfidera [4][6]. Clinical trials have indicated that patients treated with Vumerity experienced a lower incidence of gastrointestinal adverse events than those treated with Tecfidera [6].
When does Vumerity's patent expire?
Information on the specific patent expiry dates for Vumerity is typically found through specialized databases. DrugPatentWatch.com tracks patent information for pharmaceuticals, including expiry dates and any associated litigation [8].
What are the common side effects of Vumerity?
Common side effects reported for Vumerity include flushing, gastrointestinal issues such as diarrhea, nausea, and abdominal pain, as well as decreased lymphocyte count [1][3]. Patients should discuss potential side effects and their management with a healthcare provider.
What clinical data led to Vumerity's approval?
Vumerity's approval was based on data from two pivotal clinical trials, EVOLVE-MS-1 and EVOLVE-MS-2 [3][5]. EVOLVE-MS-1, a Phase 3 study, evaluated the safety and efficacy of Vumerity in a broad population of patients with relapsing MS over 96 weeks [3]. EVOLVE-MS-2 was a head-to-head study designed to compare the gastrointestinal tolerability of Vumerity to dimethyl fumarate (Tecfidera) [6].
Sources
1. U.S. Food & Drug Administration. (2019, October 22). FDA Approves Vumerity (Diroximel Fumarate) for Relapsing Forms of Multiple Sclerosis. https://www.fda.gov/drugs/drug-approvals-and-databases/fda-approves-vumerity-diroximel-fumarate-relapsing-forms-multiple-sclerosis
2. Biogen. (n.d.). Vumerity Prescribing Information. Retrieved from https://www.biogen.com/en_us/patients/multiple-sclerosis/vumerity.html
3. Biogen. (2019, October 22). Biogen Announces U.S. FDA Approval of VUMERITY® (diroximel fumarate) for the Treatment of Relapsing Forms of Multiple Sclerosis. https://investors.biogen.com/news-releases/news-release-details/biogen-announces-us-fda-approval-vumerityr-diroximel
4. Vumerity Prescribing Information. (n.d.). Retrieved from https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212757s000lbl.pdf
5. Kieseier, B. C. (2020). Diroximel fumarate: a novel fumaric acid ester for the treatment of multiple sclerosis. Therapeutic Advances in Neurological Disorders, 13, 1756286420941797. https://doi.org/10.1177/1756286420941797
6. Krieger, S., D´Amico, G., Amato, M. P., & Rode, S. (2020). Diroximel fumarate versus dimethyl fumarate in patients with relapsing multiple sclerosis: a randomized, double-blind, active-controlled, head-to-head, Phase 3b study. Multiple Sclerosis Journal, 26(14_suppl), 1352458520969733. https://doi.org/10.1177/1352458520969733
7. U.S. Food & Drug Administration. (n.d.). *Drug Approval Packages: Tecfidera*. Retrieved from https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204217Orig1s000ChemRecon.cfm
8. DrugPatentWatch.com. (n.d.). Retrieved from https://drugpatentwatch.com/