FDA Approves Bafiertam Fumarate Bioequivalent for Relapsing Multiple Sclerosis

Franck Rousseau, MD

The FDA has approved Banner Life Sciences’ Bafiertam (monomethyl fumerate) delayed-release capsules for the treatment of relapsing forms of multiple sclerosis (MS).¹

Bafietam was granted tentative approval by the FDA on November 16, 2018, after a new drug application (NDA) submitted under the 502 (b)(2) filing pathway. The drug met the required bioequivalence, safety, efficacy and quality standards for tentative approval and awaits the pending expiration of US Patient Number 7,619,001 (“the ‘001 patient”) on June 20, 2020.

Banner announced in January 2019 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, deciding that Bafiertam does not infringe on the ‘001 patient. On April 21, 2020, Banner announced that the US Court of Appeals for the Federal Circuit had upheld the earlier court’s decision, giving Banner the option to seek final FDA approval.

“The FDA’s final approval marks an important milestone for Banner and for patients living with relapsing-remitting multiple sclerosis,” said Franck Rousseau, MD, chief executive officer, Banner, said in a statement. “We are working diligently and are eager to bring this alternative treatment to physicians and patients as soon as possible.”

Banner announced that Bafiertam is contraindicated in patients with known hypersensitivity to monomethyl fumerate, dimethyl fumarate, diroximel fumarate, or to any of the excipients of bafiertam. Anaphylaxis, angioedema, progressive multifocal leukoencephalopathy have all occurred in patients who have received the drug in clinical trials before. Other warnings and precautions include Herpes Zoster and other serious opportunistic infections, lymphopenia, liver injury, and flushing.

Although there is no adequate data on the developmental risk associated with the use of bafiertam in pregnant women, patients should still inquire with their healthcare provider if they are breastfeeding, because there are unknowns about whether the drug passes into breast milk.

Results from clinical trials did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients.

“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,” Daniel Wynn, MD, FACNS, FAASM, director, Clinical Research, director Consultants in Neurology Multiple Sclerosis Comprehensive Care Center, said in a statement.

This marks yet another fumarate alternative entering the market, after the FDA granted tentative approval to Glenmark Pharmaceuticals for dimethyl fumarate delayed-release capsules, a generic of Biogen’s Tecfidera, in October 2019.²

Recently, monomethyl fumarate was 1 of 2 fumarates, in addition to diroximel fumarate, which Vitalis’s VTS-Aspirin platform was granted an orphan drug designation to be used in combination with for the treatment of fumarate flush in MS. This was announced in April 2020.³

REFERENCES

1. Banner Life Sciences announces final FDA approval of Bafiertam for multiple sclerosis [news release]. High Point, NC: Banner Life Sciences; Published April 30, 2020. Accessed May 1, 2020. businesswire.com/news/home/20200430005256/en/Banner-Life-Sciences-Announces-Final-FDA-Approval

2. Glenmark Pharmaceuticals Receives Tentative ANDA Approval for Dimethyl Fumarate Delayed-Release Capsules, 120 mg and 240 mg [news release]. Mumbai, India: Glenmark Pharmaceuticals; Published October 9, 2019. Accessed May 1, 2020. prnewswire.com/in/news-releases/glenmark-pharmaceuticals-receives-tentative-anda-approval-for-dimethyl-fumarate-delayed-release-capsules-120-mg-and-240-mg-880935531.html.

3. Vitalis Receives Orphan Drug Designation for Diroximel Fumarate and Monomethyl Fumarate, in Combination with VTS-Aspirin, for Multiple Sclerosis Patients Who Experience Fumarate Flush [press release]. New York, NY: Vitalis Pharmaceuticals; Published April 21, 2020. Accessed May 1, 2020. globenewswire.com/news-release/2020/04/21/2019255/0/en/Vitalis-Receives-Orphan-Drug-Designation-for-Diroximel-Fumarate-and-Monomethyl-Fumarate-in-Combination-with-VTS-Aspirin-for-Multiple-Sclerosis-Patients-Who-Experience-Fumarate-Flus.html