Eisai, Biogen start U.S. accelerated approval for new Alzheimer’s drug By Reuters

By Julie Steenhuysen

CHICAGO (Reuters) – Japanese drugmaker Eisai Co (OTC:) on Monday started its software course of for its experimental drug for early Alzheimer’s illness utilizing an accelerated approval pathway, the identical path that helped Eisai’s improvement companion Biogen Inc (NASDAQ:) win U.S. approval of its medicine in June.

The Biogen/Eisai drug Aduhelm was the primary Alzheimer’s remedy to win approval in almost 20 years, however the Meals and Drug Administration’s (FDA) controversial use of the accelerated approval course of – which authorizes medicine for extreme circumstances with out robust proof of a profit to sufferers – has come below heavy hearth.

Biogen and Eisai gained authorization for Aduhelm primarily based on proof that it may well scale back mind plaques, a probable contributor to Alzheimer’s, reasonably than convincing proof that it slows development of the deadly illness. Firms are required to run confirmatory research to show the drug works as supposed.

Now, Eisai, which leads improvement on Alzheimer’s drug lecanemab, is utilizing proof from a midstage trial exhibiting its drug candidate removes mind plaques to a good better diploma than Aduhelm, with decrease charges of mind swelling.

Eisai intends to study from its companion’s experiences as it really works by means of the regulatory course of. Ivan Cheung, president of Eisai’s world neurology group, mentioned in an interview the corporate is being as clear as attainable.

Eisai will submit its software to the FDA on a rolling foundation, with the goal of finishing the appliance within the subsequent few months. The corporate plans to submit information from its midstage trial of 856 volunteers, which confirmed that 80% of sufferers had no amyloid left of their brains after 18 months of remedy.

That profit additionally correlated with enhancements seen in some sufferers, Cheung mentioned. The trial was revealed in Alzheimer’s Analysis and Remedy, a peer-reviewed journal, in April.

A key level of rivalry with the Aduhelm approval is the timing of the confirmatory trial, which FDA officers mentioned may take a number of years. Eisai already has a confirmatory, Section III trial absolutely enrolled. Cheung expects outcomes earlier than the top of 2022.

“We perceive the urgency for the general public to have validating medical information,” Cheung mentioned.

The FDA initially gave Aduhelm a broad indication that went past what was studied in its trials. Cheung mentioned his firm solely needs the FDA to think about the drug’s actual examine inhabitants – early Alzheimer’s.

Eli Lilly (NYSE:) and Co mentioned in July it additionally plans to hunt accelerated approval for its Alzheimer’s candidate, donanemab, primarily based on mid-stage information. Lilly has mentioned it plans to hunt U.S. regulatory approval by yearend.