Biogen to Seek Approval for First Alzheimer’s Drug
In a major shake-up of the pharmaceutical market, Biogen announced that it intends to seek approval from the FDA for its Alzheimer’s drug aducanumab.
This follows their earlier announcement that the two clinical trials evaluating the effectiveness of the drug in patients had been discontinued. However, Biogen state that data from additional patients in the trials gave evidence that aducanumab reduced cognitive decline.
If Biogen gets approval for the drug, it will be a game-changer for the treatment of Alzheimer’s and dementia. No current drugs have been clinically approved for the treatment of Alzheimer’s, due to an overwhelming number of failures at the clinical trial stage. One reason for this is that different gene variants in patients impair the action of various drugs. Another is that many Alzheimer’s drugs are designed to prevent the build-up of amyloid plaques in the brain that contribute to the cognitive decline association with the disease. However, new research has revealed that the protein build-up may be a symptom of the disease, rather than the cause. No drugs have been developed for metabolic targets that could prevent the disease formation.
Aducanumab, however, does works by preventing the build-up of protein plaques in the brain.
In response to the news, shares of Biogen rose by 27%. Even if the drug will only help a small proportion of patients, if approved it will likely dominate the market.
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