The data showed that patients who received aducanumab experienced significant benefits on measures of cognition and function, including memory, orientation and language, according to Biogen。
The company Biogen said it will file an application with the FDA in early 2020 and will continue discussions with regulatory authorities in Europe and Japan。
Biogen公司称将在2020初年向美国食药监局FDA报批,也会和欧洲和日本的监管机构沟通。
Via CNN
是否获批仍存疑问。
“I really hope these new analyses pan out,” said Dr。 Richard Isaacson, director of the Alzheimer‘s Prevention Clinic at Weill Cornell Medicine in New York, who had patients in the original clinical studies。
“I‘m not surprised that a reanalysis of the data showed something positive,” he said, adding, “I do believe that there are going to be probably continued regulatory hurdles。” Additionally, the drug could be extremely expensive, Isaacson said。
“But is that going to be enough for the FDA to approve this from a regulatory perspective? Would payers reimburse it? I don‘t know, but I hope so,” he said。