× Biogen’s Alzheimer’s drug is unlikely to win E.U. approval.
Biogen’s Alzheimer’s drug, aducanumab, is unlikely to win approval in the European Union, according to a preliminary assessment by the European Medicines Agency.
The findings, released Friday by the European regulator, indicate that tests of the drug on healthy people who developed mild memory loss were unable to show that the drug could slow the pace of cognitive decline in patients with the most common form of the disease.
The preliminary evaluation, however, didn’t examine “whether the drug has the potential to offer benefit in patients with mild cognitive impairment with progressive disease,” the agency said.
Berenberg analyst Siraj Khaliqi said in a research note last week that he expects the drug “to get conditional approval in the US and parts of Asia to treat early stage Alzheimer’s disease by June 2020.” He maintained his buy rating on the company’s stock.
Spokespeople for the company didn’t immediately respond to request for comment.
Biogen is the latest big drugmaker to fall on the road to broad Alzheimer’s approval. In June, the U.S. Food and Drug Administration approved Eli Lilly’s entolimod for patients with early stage Alzheimer’s disease, even though the drug hadn’t been tested on people with mild to moderate symptoms. That marks the second approved Alzheimer’s drug in the U.S. since 2013.
Biogen’s drug, which is known generically as aducanumab, is also being tested on people with early stage Alzheimer’s disease. If it wins approval, it would become one of a new class of drugs called “amyloid-busting” drugs, which combats the buildup of toxic amyloid plaques in the brain by targeting the protein that forms plaques in the brain — known as amyloid precursor protein.
Amyloid is believed to play a role in disease progression by interfering with brain function. Amyloid-busting drugs are broadly seen as a last resort for patients and are designed to reduce the damaging accumulation of amyloid, hoping to alleviate symptoms for years at a time. However, these drugs can cause side effects.
Drugs from Roche and Baxalta also work in this way, but biopharmaceutical giant Biogen’s, unlike other experimental drugs, targets amyloid plaques directly.
Despite the underwhelming results on aducanumab, the drug still has significant appeal in the U.S. Berenberg analysts predict that it could be approved in the United States by June 2020.