New oral drug for multiple sclerosis: vumerity, an upgraded product of Bogen tecfidera, has been approved by the United States. Gastrointestinal tolerance has been greatly improved!

November 1, 2019 / BIOON / -- Biogen and partner Alkermes recently announced that the U.S Food and Drug Administration (FDA) has approved vumerity (diroximel Fumarate, biib098), a new oral fumaric acid drug with unique chemical structure, is used in the treatment of multiple sclerosis (RMS), including clinical isolated syndrome, relapse relief disease and active secondary progressive disease Vumerity is developed by Alkermes, and Bojian has the exclusive global authorization for the commercialization of vumerity The drug is expected to be available in the United States soon According to the terms of the license and cooperation agreement between Bojian and Alkermes, the FDA approval will trigger Bojian to pay Alkermes a $150 million milestone payment Vumerity is an immunosuppressant It is a premedical fumaric acid monomethyl ester (MMF) with controlled-release dosage form It can be rapidly converted into MMF in vivo MMF has immunomodulatory and neuroprotective effects The neuronal degeneration of multiple sclerosis (MS) is related to oxidative stress MMF has antioxidant properties, which may help to protect myelin sheath and insulating nerve fibers Specifically, MMF can activate Nrf2 pathway, participate in cell response to oxidative stress, and may protect neurons from damage The immunoregulation of MMF may be related to the inhibition of NF KB mediated pathway, and NF KB plays a key role in the immune system Vumerity is a new oral therapy for RMS It is an upgraded version of the listed drug tecfidera (dimethyl fumarate, DMF, dimethyl fumarate), which has improved gastrointestinal tolerance It has been proved to have good efficacy, safety and tolerance in clinical research Vumerity has differential gastrointestinal (GI) tolerance due to the difference of chemical structure between vumerity and tecfidera Tecfidera can be converted into MMF to play its role in vivo The recommended starting dose of the drug is 120mg every time, twice a day, lasting for 7 days After that, the maintenance dose is 240mg every day, twice a day, with meals or on an empty stomach FDA's approval of vumerity is based on a new drug application (NDA) submitted by 505 (b) (2) regulatory approach The NDA includes pharmacokinetic bridging data comparing vumerity and tecfidera to establish bioequivalence, and is based in part on FDA's safety and efficacy results for tecfidera The mid-term exposure and safety findings of evolve-ms-1, a key phase III clinical study, were also included in the drug NDA This is a single arm, open label, 2-year safety study that is assessing the long-term safety of vumerity in patients with relapsing remitting multiple sclerosis (RRMS) The interim results of the study at the time of NDA submission included a low overall incidence (6.3%) of vumerity treatment interruptions due to adverse events, and less than 1% of vumerity treatment interruptions due to gastrointestinal (GI) adverse events Other exploratory efficacy endpoints of the study showed changes in clinical and radiologic indicators compared to baseline Key components of the vumerity clinical development project include evolve-ms-1 study and pharmacokinetic bridging study comparing vumerity with tecfidera In addition, Alkermes is conducting evolve-ms-2, a five week head to head gastrointestinal (GI) tolerance study to compare the tolerance of vumerity with that of tecfidera Tecfidera is a heavy MS drug of Bojian It is the largest oral MS drug in the world, and the only targeted and highly effective MS drug with more than 10 years of clinical experience In 2017, tecfidera's sales (US $4.214 billion) surpassed the peptide drug Copaxone (galatirine acetate) of TIWA / Takeda for the first time, becoming the best-selling MS drug in the world According to the 2018 performance report released by Baijian at the end of January this year, tecfidera's sales in 2018 was $4274 million In MS field, Bojian is the absolute hegemon In addition to tecbidera, Avonex (interferon β - 1A) and Tysabri (natalizumab), two other drugs of the company, also achieved global sales of US $1915 million and US $1864 million in 2018 Original source: Biogen and Alkermes announcement FDA approval of Vu Gamma (diroximel fumarate) for Multiple Sclerosis