The future of Biogen’s super-potential Alzheimer’s disease treatment came into doubt on Friday as an unusually controversial scientific panel contradicted the positive conclusions of staff at the Chinese drug regulator. States.
The board voted that the company’s key test data did not provide enough evidence that this drug, aducanumab, actually works.
Along with millions of people with Alzheimer’s disease and their loved ones, investors are still pondering over aducanumab, which will be the first new treatment for the disease since 2003 if it were approved. in U.S.A.
Just two days ago, Biogen shares soared 44% when scientists from the Food and Drug Administration said there was “substantial evidence”; that aducanumab was effective.
However, at the FDA advisory board meeting on Friday, many scientists disparaged the test data as incomplete and incomplete, and some rounded up the opinion of regulators. for accelerating the approval process.
Scott Emerson, professor emeritus of biostatistics at the University of Washington, accused Biogen of using cherry picking data to prove the drug worked, likening it to “someone who first shot a gun. Short into the warehouse and then paint a target around the bullet hole ”.
Caleb Alexander, a professor at the Johns Hopkins Bloomberg School of Public Health, said the FDA’s review appears to use the same language as Biogen has provided.
Joel Perlmutter, a professor of neurology at the Center for the Hope for Neurological Disorders, accused the FDA of trying to present data to the council as if there was “bias in that direction”.
Ten members of a panel of 11 people voted that there was not enough evidence in the study to prove the drug was effective. One member voted “not sure”.
Michel Vounatsos, chief executive officer of Biogen, said they “appreciated the opportunity” to share data with the committee and thank the patients who shared their experiences.
The FDA did not immediately respond to a request for comment.
The final decision will be made by Billy Dunn, acting director of the FDA’s neuroscience office, who is not bound by the opinion of the advisory board.
Speaking on Friday before experts voted, he said he was “highly sensitive” to the “urgent need” for Alzheimer’s drugs, and that data from the successful study was “in support. strong “for approval.
In March 2019, Biogen halted both trials of aducanumab after an independent committee said it would be ineffective. But it surprised investors last October when it claimed that a deeper analysis found the drug to be effective when taken at higher doses.
Biogen is applying for approval based on one successful trial, with a subset of data from another failing target. Proponents including Public Citizen and the National Center for Health Research have urged the FDA to ask Biogen to conduct a new test.
Aaron Kesselheim, a professor of medicine at Harvard Medical School, said the data had “red flags”, noting that the first study wasn’t even over yet. “It’s strange to rely on one-half or two-thirds of research as evidence of the effectiveness of a drug,” he said.
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