Baijian and Weicai, a Japanese pharmaceutical manufacturer, submitted a rolling declaration of lecanemab, a drug for the treatment of Alzheimer's disease, to the US Food and Drug Administration (FDA). The two companies said that the biological product license application (BLA) was submitted under the FDA accelerated approval route for the treatment of mild cognitive impairment (MCI) caused by Alzheimer's disease and mild Alzheimer's disease (collectively referred to as early Alzheimer's disease) confirmed to have cerebral amyloid pathology.
The two companies also said that a confirmatory phase III trial called clarity ad will release data in the autumn of 2022, involving 1795 patients. The two companies said that FDA agreed that the results of clarity ad could be used as a confirmatory study to verify the clinical efficacy of lecanemab. According to the test results, Weicai may submit lecanemab's full approval to FDA in fiscal year 2022.
In March this year, stifel analyst Paul matteis pointed out that he thought the probability of lecanemab being approved was about 30%. The two companies began rolling applications in September 2021. In March this year, the two companies began to submit the application data of lecanemab for the treatment of Alzheimer's disease in Japan.
As of press time, Baijian rose 2.38%.