“The FDA’s final approval marks an important milestone for Banner and for patients living with relapsing-remitting multiple sclerosis,” said Franck Rousseau, M.D., Chief Executive Officer of Banner. “We are working diligently and are eager to bring this alternative treatment to physicians and patients as soon as possible.”
“As a practicing neurologist treating patients with MS, I’m encouraged that a lower dose of BAFIERTAM is equivalent to Tecfidera and may possibly lead to improved gastrointestinal tolerability for patients, especially early in the treatment regimen,” said Daniel Wynn, M.D. FACNS FAASM, Director, Clinical Research, Director Consultants in Neurology Multiple Sclerosis Comprehensive Care Center, Chicago, Illinois.
The FDA granted tentative approval of BAFIERTAM on November 16, 2018 under a New Drug Application (NDA) submitted under the 505(b)(2) filing pathway. BAFIERTAM, a novel fumarate bioequivalent alternative to a prodrug of BAFIERTAM, Tecfidera (dimethyl fumarate) of Biogen Inc, met the required bioequivalence, safety, efficacy and quality standards for tentative approval. Final approval was pending the expiration of U.S. Patent Number 7,619,001 (“the ‘001 patent”) 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 U.S. 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.