Yan Jian and Alkermes jointly developed Vumerity (diroximel fumarate) with provisional FDA approval
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Last Update: 2020-06-07
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Source: Internet
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Author: User
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recently, Biogen and Alkermescompany(http://to develop a new recurrent type of multiple sclerosis (MS) new treatment, Vumerity (diroximel fumarate), received provisional approval for theFDA(http://About Vumerity
Vumerity is an oral fumarate with a unique molecular structureBetter gastrointestinal safety and tolerance than dimethyl fumarate, a vestium-rich metformin that has been approved for TREATMENT of MSDiroximel fumarate is a precursor to oral fumarateIt can be quickly converted into methylene sulprates in the bodyMomaracid monomethylesters can reduce damage from oxidative stress by activating a transcription factor called Nrf2In the study
patients with recurrent recurrent multiple sclerosis (RRMM) were treated with Vumerity or Tecfidera in a Phase 3 clinicaltrial (http:// called EVOLVE-MS-2 Vumerity performed significantly better at the main endpoint of the trial than Tecifidera: according to the patient's self-report, patients treated with Vumerity had significantly fewer days of severe gastrointestinal side effects than the active control group (p-0.0003) Patients who withdrew from clinical trials due to gastrointestinal side effects accounted for 0.8 percent of the Vumerity group, compared with 4.8 percent in the Tecfidera group Yan Jian and Alkermes filed Vumerity's New Drug (http:// Application (NDA) using the FDA's 505(b)(2) regulatory approach, and used Tecfidera as a reference drug (http://
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