EU Panel Recommends Negative Trend Vote On Biogen's Alzheimer Drug

(RTTNews) - Shares of Biogen Inc. (BIIB) are down on Wednesday after the advisory committee of the European Medicines Agency recommended a "negative trend vote" for the company's Alzheimer's therapy drug Aducanumab.

The "negative trend vote" by the EU's Committee for Medicinal Products for Human Use comes after an oral explanation was provided last month.

Commenting on the development, Priya Singhal, head of global safety and regulatory sciences and interim head of research and development at Biogen, said, "While we are disappointed with the trend vote, we strongly believe in the strength of our data and that aducanumab has the potential to make a positive and meaningful difference for people and families affected by Alzheimer's disease."

The EU advisory committee is anticipated to announce a formal decision on the drug when it meets again in the middle of December. Analysts are of the opinion that the EU advisory committee is not expected to change its recommendation and the feedback will most likely be negative.

In June, the FDA had given approval to the drug even though the outside group of experts had said that the material supporting the drug was not that strong.

The FDA approval had at first skyrocketed Biogen shares up 38.3 percent in a single day, but negative feedback of the approval, displeasure about the early rollout and the fast development of similar drugs by competitors drove the stock downwards and it has fallen 34 percent since June.