FDA approves of Bafiertam for MS 

May 04, 2020
Banner Life Sciences announced the U.S. Food and Drug Administration granted final approval of Bafiertam (monomethyl fumarate) delayed-release capsules for the treatment of relapsing forms of multiple sclerosis. Bafiertam is a prescription medicine used to treat relapsing forms of MS – including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease – in adults.

The FDA granted tentative approval of Bafiertam in November 2018. Bafiertam, a novel fumarate bioequivalent alternative to Tecfidera (dimethyl fumarate) met the required bioequivalence, safety, efficacy, and quality standards for tentative approval. Final approval was pending the expiration of the U.S. patent in June protecting Biogen’s Tecfidera, or the outcome of pending litigation between Banner and Biogen regarding the patent. 

In January 2019, Banner announced that the U.S. District Court for the District of Delaware had ruled in favor of Banner’s motion for judgment on the pleadings against Biogen, deciding Bafiertam does not infringe the patent, thus permitting Banner to seek final FDA approval. In April, Banner announced that the United States Court of Appeals upheld the earlier court’s decision.

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