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CompilationTom Lee
A few days ago, the European Commission for Medicinal Products for Human Use (CHMP) announced the recommendation of Bojian Vumerity (diroximelfumarate) for the treatment of patients with relapsing-remitting multiple sclerosis (RRMS)
.
Vumerity is a new generation of oral fumarate developed by Biogen.
Its active ingredient is the same as that of Biogen's other blockbuster drug for multiple sclerosis, Tecfidera, which is currently facing generic competition
.
The drug can reduce the recurrence rate of multiple sclerosis, slow the progression of disability, and affect the number of brain lesions in patients with multiple sclerosis
The CHMP's positive opinion on Vumerity this time is mainly based on the long-term safety and effectiveness of Tecfidera, as well as data from the pharmacokinetic bridging study of Vumerity and Tecfidera
.
The EVOLVE-MS-2 study is a large, randomized, double-blind, five-week phase 3 trial that compares the gastrointestinal (GI) tolerance of Vumerity and Tecfidera in patients with relapsing-remitting multiple sclerosis
In 2017, Tecfidera's sales (US$4.
214 billion) surpassed Teva and Takeda's peptide drug Copaxone for the first time, becoming the world's best-selling multiple sclerosis drug
.
After being approved by the U.
Multiple sclerosis is one of the most common central nervous demyelination diseases, including clinically isolated syndromes, relapsing-remitting diseases, and secondary progressive diseases, which have a huge impact on people affected by the disease and their caregivers
.
Bojian has been researching in the field of multiple sclerosis for more than 25 years
In 2020, Bojian reported that Tecfidera’s sales reached US$3.
84 billion, but according to GlobalData’s forecast, Tecfidera’s revenue by 2026 will only be US$1.
12 billion due to competition from generic drugs
.
According to Bojian’s 2021 semi-annual report released in July, operating income in the first half of the year was US$5.
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