Eisai Co, a Japanese pharmaceutical, started the application process for its experimental treatment for early Alzheimer’s disease on Monday, following the same fast approval pathway that helped Eisai’s research partner Biogen Inc obtain U.S. clearance for its medication in June.
The Biogen/Eisai drug Aduhelm was the first Alzheimer’s treatment to receive FDA approval in nearly 20 years, but the FDA’s controversial use of the accelerated approval process – which allows drugs for severe conditions to be approved without strong proof of patient benefit – has drawn widespread criticism.
Aduhelm was approved by the FDA based on data that it can decrease brain plaques, a known factor to Alzheimer’s disease, rather than compelling proof that it slows the illness’s progression. Companies must conduct confirmatory trials to demonstrate that the medication performs as planned.
Eisai, which is leading the development of the Alzheimer’s medication lecanemab, is now citing data from a midstage study that shows their drug candidate eliminates brain plaques even more effectively than Aduhelm while causing less brain swelling.
As it goes through the regulatory procedure, Eisai aims to benefit from its partners’ experiences. In an interview, Ivan Cheung, president of Eisai’s worldwide neurology group, stated that the business is being as open as possible.
Eisai plans to submit its application to the FDA on a rolling basis, with the goal of finishing it in the coming months. After 18 months of therapy, 80 percent of patients had no amyloid remaining in their brains, according to results from the company’s midstage trial of 856 volunteers.
That benefit also correlated with improvements seen in some patients, Cheung said. The trial was published in Alzheimer’s Research and Therapy, a peer-reviewed journal, in April.
A key point of contention with the Aduhelm approval is the timing of the confirmatory trial, which FDA officials said could take several years. Eisai already has a confirmatory, Phase III trial fully enrolled. Cheung expects results before the end of 2022.
“We understand the urgency for the public to have validating clinical data,” Cheung said.
The FDA first awarded Aduhelm a wide indication that extended beyond the studies’ findings. Cheung stated that his business solely wants the FDA to take into account the drug’s precise trial population – those with early Alzheimer’s disease.
In July, Eli Lilly and Company said that, based on mid-stage data, it intends to pursue expedited clearance for its Alzheimer’s candidate, donanemab. Lilly has stated that it intends to seek regulatory clearance in the United States before the end of the year.