Image copyright Getty Images Image caption Biogen is developing a new anti-amyloid drug for the disorder
The European Commission has denied permission for the US drug company Biogen to sell a new Alzheimer’s treatment in the EU.
The EMA had recommended Biogen’s anti-amyloid drug, aducanumab, as a treatment for Alzheimer’s disease.
It needs regulatory approval from the European Commission to be market-ready for the EU market.
It is the first time in five years Biogen has not been able to sell a drug in the E.U.
The EMA approved another Alzheimer’s drug, bapineuzumab, from another US company, Eli Lilly, a year ago.
This drug was the first of several for the condition since 2010, after earlier treatments from Pfizer and Johnson & Johnson fell short of expectations.
Biogen’s decision to ditch the drug also means Germany’s Gerresheimer will no longer have to sell its Amyloid Basal Glutamate Substitution (ABG) gene therapy for a variety of neurodegenerative diseases in the EU.
Gesundheit! Geldmündlung https://t.co/FMsh8yfkTf — Kathy Harvey (@kharveymx) November 2, 2018
Biogen shares fell 14.9% in morning trading in New York on Friday, after a report from Bloomberg News suggested the European Commission’s rejection was due to concern about the cardiovascular effect of the treatment.
Biogen said it disagreed with the report’s “scope and interpretation”.
Its president, George Scangos, said the Commission’s decision would now leave it in a position to either launch the drug in Europe, or to compete with another drug from Eli Lilly.
“We continue to believe the new study [being undertaken by the EU] will provide clarity in our interactions with the Commission,” he said.