Biogen Alzheimer's drug gets negative EU Regulator opinion

[CAMBRIDGE] A key panel of the European Union's drugs regulator issued a negative opinion on Biogen's controversial treatment for Alzheimer's disease, dimming the hopes for marketing the drug in the region.

The committee said that while Aduhelm reduces amyloid beta in the brain, the link between that and clinical improvement hasn't been proven. The panel also said the studies didn't show the drug was safe enough, as some brain scans of patients suggested abnormal swelling or bleeding.

Shares of Biogen fell 4.2 per cent in early trading before US markets opened. Eisai Co, Biogen's development partner on the drug, fell 2 per cent in Tokyo before the decision was announced.

The companies said they will ask the panel to reexamine the opinion, a process that takes about two months upon receipt of the necessary documents.

An EMA panel had given "a negative trend vote" on the US drugmaker's application for Aduhelm last month, signalling a likely rejection. Such a move "effectively wipes away 40 per cent of potential future revenue," Brian Abrahams and other analysts at RBC Capital Markets wrote in a note to clients at the time.

The committee conducts initial assessments for drug companies applying for marketing authorisation throughout the EU, and its opinions precede the ultimate decision of the European Medicines Agency. Biogen conducted two large trials of the drug's effect on Alzheimer's patients with mild cognitive impairment that yielded conflicting results.

The June approval of Aduhelm in the US sparked uproar, with some members of the outside committee that advised regulators resigning in protest. Meanwhile, patient groups cheered the arrival of the first therapy that aims to alter the course of the disease.

Uptake in the US has been slow as private health insurers and government programmes weigh whether to pay for the drug. Some doctors said the benefits, if they exist at all, aren't clinically meaningful and don't outweigh potential side effects including brain swelling.

BLOOMBERG