Biogen and Eisai will seek U.S. approval for the Alzheimer’s treatment aducanumab, which works on a similar principal as BioArctic’s BAN2401.
Biogen and Eisai decided to end the two late-stage trials of aducanumab in March when a so-called “futility analysis” revealed the trials had little hope of succeeding, reports Reuters. However, Biogen has now said that more data had become available after the two studies were discontinued, resulting in new analysis that showed one of the trials met the main goal, while the other did not. Results from patients in the failed second trial who had received high doses also supported the findings of the first, it added. Patients who received aducanumab experienced significant benefits on measures of cognition and function such as memory, orientation and language.
BioArctic’s share increased by over 50 percent
Swedish BioArctic is developing the competing drug candidate BAN2401 together with Eisai and after this announcement the company’s share increased by over 50 percent. BAN2401 works on a similar principal and is also being jointly developed along with Eisai.
BAN2401 is in a global confirmatory phase 3 study in Alzheimer’s patients.
“With BAN2401’s positive and robust results in the phase 2b study in 856 patients with early Alzheimer’s disease, and the ongoing confirmatory phase 3 study, BAN2401 has the possibility to be the first disease-modifying treatment for Alzheimer’s. If we succeed, it would represent a significant paradigm shift in the standard of care and address huge unmet medical needs,” says Gunilla Osswald, CEO, BioArctic.
FDA application in the beginning of 2020
An application for aducanumab will be sent to the FDA in the beginning of 2020 and Biogen and Eisai will initiate discussions with authorities on international markets like Europe and Japan.
Read a longer interview with Gunilla Osswald in our upcoming issue of the magazine!