Biogen receives priority review for Alzheimer’s drug candidate
Biogen (NASDAQ:BIIB) announced that the FDA has accepted its Biologics License Application for aducanumab. The application has been granted Priority Review and its PDUFA date has been set at March 7, 2021. The agency has stated that it may take earlier action than the date. The company is collaborating with Eisai Co. Ltd. of Japan for developing this investigational treatment for Alzheimer’s disease.
Aducanumab has the potential to become the first treatment to bring significant change in the course of the disease for patients. The drug candidate has been through EMERGE and ENGAGE, which were Phase 3 multicenter, randomized, double-blind, placebo-controlled, parallel-group studies. The primary endpoint of the trial was to assess the efficacy of monthly doses of aducanumab in mitigating cognitive and functional impairment. The secondary endpoints were to evaluate the impact of monthly doses of the drug candidate on clinical decline.
The company has also used data from a Phase 1b study, in conjunction with data from Phase 3 studies. These trials assessed the drug candidate in patients with early-stage and mild Alzheimer’s. In EMERGE, patients who were administered the highest dosage of Aducanumab showed statistically significant improvement on a clinical dementia scale. However, the same patient group in the ENGAGE demonstrated worse performance than patients on placebo. The group also performed worse on a test of cognitive tests.
Aducanumab have had a chequered past as it had failed a futility analysis in March 2019. This failure had prompted the company to halt its Phase 3 program. However, it was reconstituted later by Biogen claiming that the additional data had demonstrated the drug candidate’s potential to reduce clinical decline.
Biogen stated that it did not use its Priority Review voucher and that the status was granted by the FDA on
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