American biotech company Baijian and its Japanese partner Weicai announced on the morning of August 7 local time that the food and Drug Administration of the United States has accepted the marketing license of the company’s Alzheimer’s disease treatment drug “aducanumab”, which is expected to be approved on March 7, 2021.
Baijian said the FDA would plan to implement a rapid review. If approved, it would be the first drug on the market to improve Alzheimer’s disease.
“aducanumab” is a human monoclonal antibody against amyloid protein, which can selectively bind the deposited protein in the brain of Alzheimer’s disease patients and clean up the brain.
according to the previous report, Baijian used “aducanumab” in the clinical development stage five years ago to conduct two phase III clinical trials named emerge and emgage for patients with early Alzheimer’s disease and patients with mild Alzheimer’s disease. However, the trial was terminated and failed in March 2019 because an analysis showed that the drug had a less than 20% chance of slowing down cognitive decline.
in October of that year, Baijian announced again that in a larger analysis, large doses of drugs can alleviate the symptoms of early patients. After reusing large doses of drugs, most patients have reduced amyloid protein content in their brains and can live independently for longer periods, including housework and traveling alone.
after the announcement of the above results, Baijian company said that it planned to apply for the listing permission of “aducanumab” in the United States, and successfully submitted it in August this year and obtained the priority review right.
in the report on the 9th, the FDA expected to review the function and feasibility of the drug within six months. If it is successful, it will be the first drug for Alzheimer’s disease that has passed the FDA’s review, and will apply to all parts of the world for permission to sell drugs starting from the United States.
in this regard, Michelle warnasos, CEO of Baijian, believes that “aducanumab” will become a historic milestone in the treatment of Alzheimer’s disease.
Samantha Benham hermetz, director of policy and public affairs at the Alzheimer’s research center in the UK, also expressed his expectation for the application. “Alzheimer’s patients have been waiting for too long.” “It’s gratifying that this devastating disease has always been a priority for the FDA,” she said. I’m glad we’ve been able to move from the unknown to the present, but we’re still in an unknown area, and we need to continue to explore. “