Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. The concerns over the limited use of the drug, however, dragged the shares down to settle 8% lower. That makes the label narrower than that in Europe, which allows use in all adults with late-onset Pompe disease. At least one analyst said the drug's label, which restricts its use only to switch patients, weighed on the drugmaker's shares. Amicus said it would launch the therapy immediately in the U.S. with a list price of around $650,000 for a patient weighing about 70 kilograms.

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Persons: Andrew Kelly, Needham, Gil Blum, Sriparna Roy, Shinjini Ganguli, Sriraj, Shweta Agarwal Organizations: Food and Drug Administration, FDA, REUTERS, Amicus Therapeutics, U.S . Food, Sanofi, Amicus, Thomson Locations: White Oak , Maryland, U.S, Europe, Sanofi, Bengaluru