30 April 2020 - - The US Food and Drug Administration granted final approval of Bafiertam (monomethyl fumarate) delayed-release capsules for the treatment of relapsing forms of multiple sclerosis, US-based pharmaceutical company Banner Life Sciences LLC said.

The FDA granted tentative approval of Bafiertam on November 16, 2018 under a New Drug Application submitted under the 505(b) (2) filing pathway.

Bafiertam, a novel fumarate bioequivalent alternative to a prodrug of BAFIERTAM, Tecfidera1 (dimethyl fumarate) of Biogen Inc, met the required bioequivalence, safety, efficacy and quality standards for tentative approval.

Final approval was pending the expiration of US Patent Number 7,619,001 on June 20, 2020 protecting Biogen's Tecfidera, or the outcome of pending litigation between Banner and Biogen regarding the patent.

In January 2019, Banner announced that the US District Court for the District of Delaware had ruled in favor of Banner's motion for judgment on the pleadings against Biogen, Inc. deciding Bafiertam does not infringe the '001 patent, thus permitting Banner to seek final FDA approval.

On April 21, 2020, Banner announced that the United States Court of Appeals for the Federal Circuit had upheld the earlier Court's decision.

Bafiertam is a prescription medicine used to treat relapsing forms of multiple sclerosis, to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.

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.