On 28 Apr. 2020, USFDA approved Banner lifescience’s Bafiertam (Monomethyl fumarate delayed release capsules). Currently there are two other monomethyl fumarate prodrugs available in the USA namely Dimethyl fumarate (Tecfidera) and Diroximel fumarate (Vumerity).
Regarding Bafiertam, Banner has submitted NDA under 505(b)(2) filing pathway taking Tecfidera as Reference product. Indication of Bafiertam is same as that of Tecfidera and Vumerity.
With respect to patent litigation between Banner and Biogen, 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 (See here).
Comparison between Bafiertam, Tecfidera and Vumerity is available below:
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