In Surprise Turnaround, Biogen to Submit Previously Failed Alzheimer Drug for Approval
RandomFactor writes:
In an extremely rare reversal, the biotech company Biogen said that it will submit the experimental amyloid beta targeting drug aducanumab-which previously had its drug trial stopped as futile-to the Food and Drug Administration for approval.
The company said a "new analysis of a larger dataset" showed that the drug, aducanumab, reduced clinical decline in patients with early Alzheimer's disease on multiple measures of the drug's effectiveness. That directly contradicts a decision in March to halt studies of the therapy based on the recommendations of an independent monitoring board that was charged with protecting patients in the study.
The reversal came about because the decision to halt the study was made based on an early part of the dataset where the dosage was reduced in an effort to avoid a potential side effect. When results on patients exposed to higher doses in later portions of the study was available and factored in the results turned significant.
Biogen said that it conducted a new analysis in consultation with the FDA of a larger data set from the discontinued studies. The new analysis includes additional data that became available after the previous analysis showed the studies were "futile" - that it had no chance of succeeding. Biogen said that the new data show aducanumab is "pharmacologically and clinically active" and that it reduced patients' clinical decline based on the results of a survey called Clinical Dementia Rating-Sum of Boxes (CDR-SB), which was the main goal of both studies.
After praising the announcement as "a testament to Biogen's steadfast determination to follow the science and do the right thing for patients,"
Michel Vounatsos, Biogen's chief executive, said in a statement. "We are hopeful about the prospect of offering patients the first therapy to reduce the clinical decline of Alzheimer's disease and the potential implication of these results for similar approaches targeting amyloid beta."
There is still discussion going on and analysts are examining and questioning the results, but with tens of millions affected by the disease worldwide, there is now a glimmer of hope.
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