The British Medicines and Healthcare Products Administration (MHRA) recently approved Bojian Vumerity (diroximel fumarate), the next-generation fumaric acid oral therapy for the treatment of relapsing-remitting multiple sclerosis (RRMS). Just recently, Vumerity was also approved by the European Commission (EC).

Vumerity is the upgraded version of Tecfidera (Chinese trade name: Tefeida, common name: dimethyl fumarate, dimethyl fumarate), a fumaric acid product that Bojian has listed. Vumerity is a new type of oral fumaric acid drug with a unique chemical structure. After oral administration into the body, it will quickly be converted into monomethyl fumarate (MMF). Tecfidera also works by transforming into MMF in the body.

The approval of Vumerity by the MHRA and EC is based on the data of the bridging study comparing the pharmacokinetics of Vumerity and Tecfidera, partly based on the good long-term efficacy and safety profile established by Tecfidera, and the results of the EVOLVE-MS-2 study.

The EVOLVE-MS-2 study is a large-scale, randomized, double-blind, 5-week, multi-center Phase 3 study to evaluate the gastrointestinal (GI) tolerance of Vumerity and Tecfidera in RRMS patients. The data shows that the overall treatment interruption rate of patients receiving Vumerity treatment is lower than that of patients receiving Tecfidera treatment (1.6% and 6%, respectively). In addition, Vumerity's treatment interruption rate due to GI tolerance was also lower than that of Tecfidera (0.8% and 4.8%, respectively). 32.8% of patients treated with Vumerity reported flushing, compared with 40.6% of patients treated with Tecfidera. There were no serious flushing events or withdrawals due to flushing during the study.

Vumerity was first approved by the US FDA in October 2019. Since its launch, real-world data has strengthened Vumerity's positive gastrointestinal tolerance profile and confirmed that clinical trial experience is consistent with clinical practice experience. According to the performance report released by Bojian, Vumerity's sales continued to grow after its listing, breaking through 100 million U.S. dollars in the third quarter of this year, reaching 121 million U.S. dollars, compared with 15 million U.S. dollars in the same period last year.

Bojian Chief Medical Officer Maha Radhakrishnan, MD, pointed out that the approval of Vumerity is an important step to improve the compliance of patients with RRMS, and the drug can have a significant impact on the results of treatment that affect patients' daily lives. Vumerity will bring a new oral treatment option for MS patients to meet their personal preferences and needs. The drug has good efficacy and positive gastrointestinal tolerance, and will continue to be evaluated in the real environment.

Reference source: MHRA authorises Vumerity for multiple sclerosis patients