Eisai launch bid for accelerated FDA approval for new Alzheimer’s drug

pharmafile | September 28, 2021 | News story | Manufacturing and Production, Medical Communications, Research and Development  

Japanese drug maker Eisai has launched a bid for accelerated FDA approval for its new experimental drug for early Alzheimer’s disease.

Eisai was the development partner of Biogen for the development of its own Alzheimer’s treatment, Aduhelm, which controversially gained FDA approval earlier this year.

Read: FDA acting commissioner seeks review of controversial Alzheimer’s drug approval

Aduhelm was the first Alzheimer’s treatment to win approval in nearly 20 years, but has since been plagued with controversy as the use of the accelerated approval process – which authorises drugs for severe conditions without strong proof of a benefit to patients – coming under heavy fire.

Authorisation was gained based on evidence that it can reduce brain plaques, a likely contributor to Alzheimer’s, rather than convincing proof that it slows progression of the lethal disease. Companies are required to run confirmatory studies to prove the drug works as intended.

Now, Eisai, which leads development on Alzheimer’s drug lecanemab, is using evidence from a midstage trial showing its drug candidate removes brain plaques to an even greater degree than Aduhelm, with lower rates of brain swelling.

In the study, out of 856 volunteers 80% of patients had no amyloid left in their brains after 18 months of treatment.

Read: Biogen withdrew Aduhelm paper when asked for edits from JAMA

Eisai intends to learn from its partner’s experiences as it works through the regulatory process. Ivan Cheung, president of Eisai’s global neurology group, said in an interview the company is being as transparent as possible.

Eisai will submit its application to the FDA on a rolling basis, with the aim of completing the application in the next few months.

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 from this trial by the end of 2022, he said: “We understand the urgency for the public to have validating clinical data.”

Read: US Veterans Health Administration rejects Biogen Alzheimer’s drug

The FDA initially gave Aduhelm a broad indication that went beyond what was studied in its trials. Cheung said his company only wants the FDA to consider the drug’s exact study population – early Alzheimer’s.

Kat Jenkins

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