Biogen Alzheimer’s Drug Slapped With Negative EU Opinion

Biogen Inc.’s controversial drug for Alzheimer’s disease was approved in the US over the summer. It was hailed as one of the most significant breakthrough treatments for degenerative brain diseases in years. But hopes to market the drug abroad, especially in Europe, have dimmed this morning after a European authority published a negative opinion on Aduhelm, according to Bloomberg. 

Aduhelm’s accelerated approval pathway in the US — led to its approval in June. The drug works by reducing a protein called amyloid-beta from the brains of the patients for memory-robbing diseases. Biogen conducted two large clinical trials of the drug’s effect on Alzheimer’s patients with mild cognitive issues that produced conflicting results. There was discontent among folks in the medical community about the approval. Meanwhile, patient groups were enthusiastic that the first therapy to possibly slow the degenerative brain disease was available in nearly two decades. 

However, come to find out on Friday, an advisory committee to the European Medicines Agency slapped Aduhelm with a negative opinion, hindering its ability to become a marketable drug in Europe. 

The Committee for Medicinal Products for Human Use said even though Aduhelm reduces amyloid-beta in the brain, there were conflicting results that the new treatment didn’t lead to an overall improvement in early-stage Alzheimer’s among patients.  

“This decision is aligned to the negative trend vote of the committee in November 2021. Biogen will seek a re-examination of the opinion by the CHMP,” said Biogen, referring to the Committee for Medicinal Products for Human Use.

As a result of the news, Biogen slid 2% premarket. 

Biogen may request re-examination within the next two weeks of receiving today’s opinion.