With the approval of the Alzheimer’s drug Leqembi, from pharmaceuticals Elisai and Biogen, in the United States, Wall Street analysts said they hope health regulators in other regions will follow suit, even if they share similar concerns about a potentially serious side effect.
Leqembi gained standard approval from the US Food and Drug Administration (FDA) on Thursday, but the FDA put its strongest “boxed” safety warning on the drug’s label, signaling the risk of potentially dangerous brain swelling in it and similar medications.
Outside the United States, Eisai and Biogen are seeking approval for Leqembi, whose chemical name is lecanemab, in Japan, the European Union, China, Canada, the United Kingdom and South Korea.
A decision in Japan is expected by the end of September, and in Europe later in the year.
Analysts expect Europe to approve the drug, but said it is not certain. European experts told Reuters earlier this year that they expect a cooler reception to the drug.
Myles Minter, an analyst at William Blair, said the European Medicines Agency (EMA) tends to be more conservative than the FDA. As such, investors will be mindful of the agency’s expert committee opinion on the drug’s safety, which comes before the EMA’s decision, Minter said.
But Minter said he still awaits approval. “We think (Europe’s regulatory agency) will follow the lead of the FDA and approve Leqembi later this year or early next year.”
