(Bloomberg) – Biogen Inc. Experimental Alzheimer’s disease treatment in the U.S. on Friday. The Food and Drug Administration failed to get the support of a panel of advisers, as the drug was placed at a crossroads due to the agency’s approval weight.
Outside experts voted 8 to 1 with 2 drawings, which were insufficient to show the functions of biogen drugs as data obtained from a single clinical trial with positive results. They also gave a 10 to 0 vote with 1 inexperienced, saying that a positive study should not be considered as primary evidence, considering the conflicting evidence of a separate trial of the drug.
The vote contradicts a report that the FDA reviewers prepared before the meeting to support the daily effectiveness of the meeting despite disagreement in an agency called Edukunumb. The FDA will continue the review process with a decision by March 7, 2021.
Advisors said the trial they were asked to assess did not end and although the data appeared positive, they could not know for sure.
“There’s a big danger of approving something that isn’t effective,” said Joel Pearlmutter, a panel member and neurology professor at St. Louis and Washington University School of Medicine in St. Louis.
The approval of biogen therapy would be a milestone in the long-term fight against Alzheimer’s, a brain-destroying disease that affects approximately 8.8 million Americans. While there are other drugs that temporarily improve some symptoms, they do not slow down or prevent the ultimate lethal destruction of brain neurons, the Alzheimer’s Association said in a report last year.
Adukunumab has also become the only significant drug for biogen, which has seen its market value fluctuate significantly over the past two years as it halts study of the drug, resumes research, and then submits it to regulators for approval earlier this year. .
Shares of Biojan were halted during a regular trading day on Friday. The stock surged% sur percent after a stimulating appraisal by FDA staff on Wednesday, although some of those gains were reversed on Thursday as Biogen fell 7.5 percent.
“We will continue to work with the FDA as it completes the review of our application,” said Michelle Wonatos, chief executive of Biogen.
The recommendations of the Advisory Committee are not binding. The FDA frequently convenes panels of experts, including researchers, medical professionals and patient representatives, when considering whether to approve a new drug. Wall Street analysts said the FDA appears to be preparing to view the drug positively.
Mizhoho analyst Salim Syed said: “The test for the FDA will be that when the FDA is at its peak and the panel appears to be on the other side, it will be at the center of the debate with science and evidence or lack thereof.” An email to Bloomberg News.
Incomprehensible way
Adukanumab targets the amyloid plaque that forms in the brains of Alzheimer’s patients, although scientists do not know what role it plays in the disease. The brain scan showed that the drug had removed the plaque, but it is unclear whether there was any benefit.
The FDA did not follow a specific procedure for advisory panels this time, starting by posting a joint report with Biogen on Educanumab’s clinical trial data ahead of the meeting. Typically, the FDA posts its own reports that outline staff reviews of the data.
The agency declined to answer questions about why it attached the report and whether it would be able to review it before Biogen was released. The agency also gave panel members the option to vote unopposed when they would normally ask for yes or no answers.
Therapy is an unconventional way for the FDA to consider. Biogen stopped his drug study in March 2019 on indications that it was not working, then revived it in October of that year, saying a review of the data in one of the two tests showed it had been successful.
Biogen, based in Cambridge, Massachusetts, presented data from two Educanumab trials at a conference in December. One trial showed that the drug could slow the progression of the disease, while another showed no effect. The researchers questioned the positive results because not all participants completed the tests.
The FDA’s clinical analyst, Kyle Crudis, said in a recorded submission to the advisory panel that trial results showing no effect of the drug on patients could not be moved from a positive trial. “I conclude that the applicant has provided substantial evidence of efficacy to support the approval,” Crudis said.
Meanwhile, Tristan Masi, the FDA’s statistical reviewer, determined that a third clinical trial was completed to determine whether adenocunumab works.
“It is unscientific, statistically inaccurate and misleading to exclude data from a large trial without adequate justification,” Masi said in a presentation prepared for the consultants.
‘Strikingly inconsistent’
Billy Dunn, director of the FDA’s Ne Phys Neuroscience at New Drugs, summarizes the agency’s opinion about the drug in a positive light at the beginning of the meeting without approving Missy’s concerns. According to the Centers for Disease Control and Prevention, he focused on ranking Alzheimer’s as the sixth leading cause of death among Americans.
“We are extremely sensitive to the need for new drugs for Alzheimer’s disease,” Dunn said.
G. Caleb Alexander, a Johns Hopkins Bloomberg School member and a public health panel member and epidemiologist, called the FDA’s content “surprisingly inconsistent” and said Messi’s statistical review was “well done.”
“It looks like the sync of audio dio and video on TV is over,” Alexander said.
If the educonumb is cleared, sales are expected to reach about $ 2.3 billion by 2025, according to data compiled by Bloomberg. Biogen developed therapies with Japanese pharmaceutical manufacturer ISKC.
Indianapolis-based Ally Lilly & Cohes Development’s many experimental Alzheimer’s drugs and the company’s stock fell as much as 4.4% after a panel vote. Like the biogen drug, Lily’s Donaneb targets a clear amyloid plaque from the brain.
(The third paragraph will add the date of the FDA’s decision, the ninth paragraph will be commented by the CEO)
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