Cogstate with its partner, Eisai Co has announced that the U.S. Food and Drug Administration (FDA) has granted Accelerated Approval for aducanumab for the treatment of Alzheimer’s disease. The approval by the FDA is the first new treatment approved for Alzheimer’s disease since 2003 and is the first approved therapy that targets the fundamental pathophysiology of the disease.
Alzheimer’s disease is the most common form of dementia, causing memory loss and other cognitive impairment that interferes with daily life. Measurement of cognition is a critical component of a diagnosis of Alzheimer’s disease.
The accelerated approval has been granted based on data from clinical trials demonstrating the effect of ADUHELM (to be marketed as ADUHELMTM) on reducing amyloid-beta plaques, a biomarker that is reasonably likely to predict clinical benefit, in this case, a reduction in clinical decline.
Dr. Stephen Salloway, Director of Neurology and the Memory and Aging Program at Butler Hospital, said, “This approval represents a major advance in the treatment of Alzheimer’s disease. By reducing amyloid-beta plaques in the brain, we are addressing one of the defining pathologies of the disease. People with Alzheimer’s disease, together with their doctors, can now decide if the treatment is right for them.”
Under the accelerated approval conditions, which provide patients suffering from the disease with earlier access to treatment, Eisai’s development partner, Biogen will conduct a controlled trial to verify the clinical benefit of ADUHELM in patients with Alzheimer’s disease. If the trial fails to verify clinical benefit, the FDA may initiate proceedings to withdraw approval of the drug.
Cogstate – Eisai agreement and implications of accelerated approval
In October 2020, Cogstate announced that it had entered into an agreement with Eisai, to grant them rights to exclusively develop and distribute Cogstate digital cognitive assessment technologies in healthcare and other markets worldwide. It is expected that such digital cognitive assessments will play an important role in supporting the type of large-scale cognitive assessment that will be necessary for the launch of disease-modifying therapies, such as ADUHELM.
Under the 10-year agreement between Eisai and Cogstate, Eisai had a right to terminate the agreement after year five under certain conditions. Following the approval of ADUHELM by the FDA, Eisai no longer has that right to accelerated termination of the Cogstate-Eisai agreement. Therefore, in addition to the upfront payment to Cogstate of US$15million (received in Dec 2020); and minimum contractual royalty payments over commercial years 1-5 of US$10 million, Eisai are now also contractually obliged to make the minimum royalty payments to Cogstate over commercial years 6-10, is an additional aggregate payment of US$20 million over that period.