In a lengthy statement released on Wednesday, FDA staff appeared to endorse Biogen’s treatment for Alzheimer’s disease. If approved, this would become the first new Alzheimer’s therapy in nearly two decades.
Alzheimer’s is a devastating neurodegenerative disease that affects more than 40 million people worldwide. It is a terminal disease that places a huge burden on families and caregivers. The main pathological mechanism of Alzheimer’s is the build-up of amyloid plaques and neurofibrillary tangles. However, an old theory suggesting that an infection might cause some cases is beginning to garner a lot of interest.
Unfortunately, there are no treatments to slow or cure Alzheimer’s disease. Within the past 20 years, only two new pharmacological therapies have become available. China is the only country to have licensed one of these therapies.
This week Biogen shares rose nearly 45%. This comes after FDA staff appeared to place their vote of confidence in Biogen’s Alzheimer’s drug – aducanumab. The drug is a monoclonal antibody that targets amyloid beta, the protein that builds up in the brain and is implicated in Alzheimer’s disease. The medication is for patients in earlier stages of disease. The apparent endorsement by FDA has caused some controversy due to the conflicting reports of efficacy.
After an early trial showed promising data, Biogen then launched two large trials to test the drug’s effectiveness. However, the company halted the trials in March 2019 after an independent committee indicated the drug was not effective. Then Biogen added more data, which suggested that the drug worked. They found that people in one trial who received the highest dose appeared to have slower cognitive decline.
While the reviewers did not explicitly call for FDA approval, their remarks appeared to support Biogen’s case. The review appeared to alleviate concerns about conflicting results and the possibility that a common side effect informed patients whether they received the treatment or placebo.
Biogen has estimated that around 1.5 million people with early stage Alzheimer’s may be eligible for aducanumab treatment. A panel of experts are convening today to decide whether to recommend the drug’s approval.
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