Seizing Aduhelm precedent, Biogen, Eisai get the ball rolling on another accelerated Alzheimer's approval
Biogen — together with partners at Eisai — will be the first to breeze down that Alzheimer’s trail it blazed with the FDA’s historic and controversial accelerated approval of Aduhelm.
Eisai disclosed it’s initiated a rolling BLA submission for lecanemab, or BAN2401, the anti-amyloid beta antibody that Biogen has long touted as a follow-on to Aduhelm (then aducanumab). Following the precedent that the agency has now set, the two companies are gunning for an OK based on data suggesting that the drug could lower amyloid beta plaques.
They won’t be alone in the queue for long. Roche and Eli Lilly are hot on their heels to join the gold rush, with the latter having also pledged to file by the end of the year.
Unlike with Aduhelm, whose approval was cemented by mixed data viewed negatively by the FDA’s advisory committee, the lecanemab filing only comes with Phase IIb data, including those from the open-label extension. The trial, dubbed Study 201, enrolled 856 patients with early Alzheimer’s and confirmed amyloid pathology.
“The lecanemab Clarity AD Phase 3 clinical trial in early AD is ongoing and completed enrollment in March 2021 with 1,795 patients,” Eisai wrote in a statement. “The U.S. FDA has agreed that the results of Clarity AD, when completed, can serve as the confirmatory study to verify the clinical benefit of lecanemab. Blinded safety data from Clarity AD will be included to support the BLA.”
A spokesperson added the primary endpoint readout for Clarity AD is expected in late 2022.
Discussions go at least as far back as August, when Eisai R&D chief Ivan Cheung told analysts his team had started talking to the FDA and seeking its advice on submitting lecanemab to the agency. Weeks before that, the drug was granted breakthrough therapy designation by the agency.
If lecanemab does follow in the path of Aduhelm and nab an expedited green light, it would further test the limits of payers and doctors, who have already proven much less welcoming to Aduhelm than regulators (or at least the neuro division) were. As Endpoints News first reported, the VA decided against including the drug in its formulary. Certain private insurers have reportedly declined to cover the drug, pending the national coverage decision by CMS; some treatment centers say they won’t administer the drug, and more recently, one center in Washington, DC even banned Biogen representatives from the premises.
ICER, a drug pricing watchdog, added another loud voice to the chorus by blasting Aduhelm’s $56,000 price tag — amid a slate of investigations where lawmakers demanded answers on how the drug was approved.
Vounatsos said in the latest press release: “It is our vision that patients and their families have choice and access to multiple treatment options for Alzheimer’s disease.”
While Aduhelm is designed to clear insoluble amyloid plaques, lecanemab mostly targets soluble protofibrils — larger oligomers thought to contribute to the neurodegeneration characteristic of Alzheimer’s.
So far, it’s been positioned for patients with early Alzheimer’s, meaning those with mild cognitive impairment due to the disease or mild forms of it.
“We recognize the strong and urgent expectations from stakeholders to further advance a treatment system for this disease,” Eisai CEO Haruo Naito said.