Generics
Banner Receives FDA Tentative Approval for Bafiertam for the Treatment of Relapsing Forms of Multiple Sclerosis
2 January 2019 - - The US Food and Drug Administration granted tentative approval on November 16, 2018 of US-based specialty pharmaceutical company Banner Life Sciences LLC's New Drug Application (NDA 505(b) for Bafiertam, a novel fumarate bioequivalent alternative to a prodrug of Bafiertam, Tecfidera (dimethyl fumarate) of Biogen, Inc., as a treatment for patients with relapsing forms of multiple sclerosis, the company said.

According to the letter, Bafiertam meets the required bioequivalence, safety, efficacy and quality standards for approval.

At present, full FDA approval is expected following the expiration of US Patent Number 7,619,001 on June 20, 2020 and anticipated ahead of generic erosion.

Approval may be accelerated based on the outcome of pending litigation with Biogen regarding this patent.

In September of 2018, Biogen Inc., dismissed its lawsuit against Banner in which Biogen had claimed Bafiertam would infringe on Tecfidera patents 7,320,999 and 8,399,514, thus granting Banner freedom to operate after the expiration of the '001 patent.

Relapsing-remitting multiple sclerosis, the most common form of MS, is a debilitating autoimmune disease characterized by inflammatory attacks to the central nervous system followed by periods of remission.

RRMS affects approximately 85% of patients diagnosed with MS, or an estimated 2m people worldwide.

There is no cure for MS and disease progression and degree of impairment vary widely by patient depending on the location and extent of nerve damage.

Treatment regimens for RRMS focus on symptom management, slowing disease progression and reducing relapses.

Bafiertam, a novel fumarate, is indicated for the treatment of patients with relapsing forms of multiple sclerosis.

While Bafiertam has been shown to activate the nuclear factor (erythroid-derived 2)-like 2 pathway, the precise mechanism of action has not been fully elucidated.

The prodrug of Bafiertam was shown in two separate studies to reduce the risk of relapse by 49% and 34%, and to reduce the number of relapses by 53% and 44%, compared to placebo. 
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