The U.S. Food and Drug Administration (FDA) has agreed to review Alkermes’ request to approve diroximel fumarate (BIIB098) as a treatment for relapsing forms of multiple sclerosis (MS), the company announced.
A final decision by the FDA is expected in the fourth quarter of 2019. If approved, diroximel fumarate likely will be marketed in the U.S. with the brand name Vumerity.
The submitted new drug application (NDA), now accepted for review, was supported by clinical data from the pivotal Phase 3 clinical trial EVOLVE-1 (NCT02634307) that showed the long-term safety and effectiveness of the investigational therapy in patients with relapsing-remitting MS (RRMS).
“We believe diroximel fumarate has the potential to be a meaningful new offering for patients with MS, and we look forward to continued engagement with the FDA throughout the review process,” Craig Hopkinson, MD, said in a press release. Hopkinson is chief medical officer and senior vice president of medicines development and medical affairs at Alkermes.
Diroximel fumarate, also known as ALKS 8700, is a compound that is taken orally and rapidly converted into monomethyl fumarate (MMF). The compound is being developed by Alkermes in collaboration with Biogen.
Although its mode of action is not fully understood, MMF is believed to have fewer gastrointestinal side effects than Tecfidera (dimethyl fumarate, marketed by Biogen), an FDA-approved oral therapy for relapsing MS.
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Supported by the ability of diroximel fumarate to modulate immune responses and reduce oxidative stress, this new oral therapy is expected to help prevent the degeneration of myelin (the nerve cells’ protective sheath) in MS patients without inducing a systemic inhibition of the immune system.
“The NDA filing acceptance for diroximel fumarate further demonstrates the productive collaboration between Alkermes and Biogen, and brings us closer to our shared goal of offering a new therapeutic option for people with MS,” Hopkinson said.
The ongoing EVOLVE-1 trial is being conducted at 108 U.S. and European clinical sites to further assess the effects of diroximel fumarate given twice daily to about 930 RRMS patients.
Data collected after one year of treatment showed a decline to 0.16 in the annualized relapse rates of 570 patients. In addition, preliminary data from brain magnetic resonance imaging (MRI) scans revealed that patients had significantly fewer active brain lesions, compared to before they took diroximel fumarate.
A previous analysis found diroximel fumarate to be generally safe and well-tolerated, with patients having a low incidence of gastrointestinal reactions, and without reports of serious side effects. Most common side effects associated with the treatment included flushing (redness of the skin, normally in the neck and cheeks), itchy skin, and diarrhea.
“For more than two decades Biogen has been at the forefront of delivering new medicines to MS patients. We are encouraged by the FDA’s acceptance of the NDA for diroximel fumarate, which we believe could help elevate the treatment of this complex and often debilitating disease,” said Michael Ehlers, MD, PhD, executive vice president of research and development at Biogen.
Alkermes is currently recruiting RRMS patients for a second Phase 3 trial (NCT03093324) called EVOLVE-2. The open-label study is taking place in clinical sites across the U.S. and Europe, and will explore the long-term safety of diroximel fumarate, in particular its gastrointestinal effects, in comparison to Tecfidera, both given twice a day.
For more information, visit the trial page.