On Thursday, the European Medicines Agency (EMA) announced that it was calling off a review of the company’s drug natalizumab, which was recently shown to have promising results in the early stages of Alzheimer’s disease. The EMA’s decision to t scend the review does not bode well for the drug’s commercial prospects in Europe.
Meanwhile, European health regulators have already signaled that they are likely to approve the use of Aricept, one of the four treatments on the E.U.’s approved list for treatment of Alzheimer’s, by late 2018.
The news is also a setback for Biogen, which won Food and Drug Administration approval for its first Alzheimer’s treatment, aducanumab, last July. At that time, it was hailed as a breakthrough. But the drug, intended for people whose lives are already under way, showed poor results in people who had yet to develop symptoms.
An estimated 5.3 million Americans are living with Alzheimer’s disease. The disease seems to be showing no signs of slowing down, and experts believe that a cure is at least a decade away. Biogen’s previous drug, Plegridy, also showed encouraging results in the early stages of the disease in a small study.
One thing Biogen can be certain of: It has an exceptionally strong product on its hands in aducanumab. Still, they will need a lot more positive news before public approval in Europe.
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