Posted by Michael Wonder on 06 Jan 2019
Banner receives FDA tentative approval for Bafiertam for the treatment of relapsing forms of multiple sclerosis
2 January 2019 - Banner Life Sciences announced today that the U.S. FDA granted tentative approval on 16 November 2018 of the Company’s new drug application for Bafiertam, a novel fumarate bioequivalent alternative to a prodrug of Bafiertam, Tecfidera (dimethyl fumarate) of Biogen as a treatment for patients with relapsing forms of multiple sclerosis.
According to the letter, Bafietram meets the required bioequivalence, safety, efficacy and quality standards for approval. At present, full FDA approval is expected following the expiration of U.S. Patent Number 7,619,001 (‘001) on 20 June 2020 and anticipated ahead of generic erosion.
Approval may be accelerated based on the outcome of pending litigation with Biogen regarding this patent.
