Nov 17 (Reuters) – A panel of the European Medicines Agency voted against the approval of Biogen Inc. (BIIB.O) Alzheimer’s drug Aduhelm, in yet another blow to the prospect of a treatment already struggling with a slow rollout in the United States.
Shares of Cambridge, Massachusetts-based Biogen, which announced the negative vote on Wednesday, fell $ 3.17 or 1.2% to close at $ 258.38. The company’s shares have fallen about 37% since Aduhelm was approved by the US Food and Drug Administration in early June.
The panel’s recommendation will be taken into account by the EMA, which is not required to follow but usually does.
“Given the existing data and controversy surrounding the drug, we see no reason why there should be a divergence (in the EMA’s decision),” said Wedbush analyst Laura Chico.
Loss of European sales would effectively eliminate 40% of potential future Aduhelm revenue, RBC Capital Markets analyst Brian Abrahams said in a research note.
Only one of Biogen’s two key trials showed that Aduhelm can slow the rate of cognitive decline for Alzheimer’s patients, and the FDA’s decision to approve the drug was controversial.
Some members of an advisory panel to the U.S. regulator withdrew in protest, and several prominent treatment centers have publicly said they will not offer Aduhelm to patients.
On Monday, Biogen said its research director Alfred Sandrock, who led the development of the drug for Alzheimer’s disease, left the company after a 23-year period, a move that analysts called abrupt. Read more
Aduhelm, the first new treatment for memory impairment in nearly 20 years, has experienced a slow uptake in the United States as hospitals and health insurance companies await a decision to cover Medicare, the government’s health plan for people over 65. Read more
The EMA’s advisory panel decides what the supervisory authority’s recommendation on treatments, vaccines or equipment should be.
The panel, the Committee for Medicinal Products for Human Use, will take a final opinion on Biogen’s Aduhelm at a meeting in December, Biogen said.
Once the EMA has approved or rejected a product, the EU executive, the European Commission, makes the final and formal decision, which typically agrees with what the EMA has said.
Reporting of Manas Mishra and Pushkala Aripaka in Bengaluru; Edited by Anil D’Silva, Shinjini Ganguli and Richard Pullin
Our standards: Thomson Reuters trust principles.