EUROPE – European Medicines Agency (EMA) panel voted against approval of Biogen Inc’s Alzheimer’s drug Aduhelm, dealing another setback to the treatment already grappling with a slow rollout in the United States.
EMA’s panel voting against Biogen’s new Alzheimer’s drug Aduhelm, implies that the controversial treatment could be rejected by the regulator next month.
Biogen, on the other hand, has acknowledged the negative vote and stated that it would continue to collaborate with the EMA “as it considers next steps toward the goal of providing access” to Aduhelm.
The Committee for Medicinal Products for Human Use is expected to complete its review of the drug at a December meeting. Aduhelm is unlikely to receive EMA approval unless the committee changes its mind.
Priya Singhal, Biogen’s head of global safety and regulatory sciences, said the company was “disappointed” with the vote but “strongly believed in the strength of our data” and the drug’s ability to help Alzheimer’s patients.
The drug, which is administered as an infusion, was approved by US regulators in June, making it the first new Alzheimer’s treatment in nearly two decades that aims to slow the progression of the neurological disease.
Biogen has stated that it hopes the treatment will become a blockbuster drug, capable of increasing revenue at a time when many of its existing products are facing competition.
However, Aduhelm’s approval in the United States has sparked a storm of controversy, with some scientists claiming there is scanty scientific evidence that it works.
Following the Aduhelm controversy, the US health department’s inspector-general announced in August a review of the FDA’s accelerated approval process for drugs.
Healthcare providers and insurers in the United States have been slow to embrace the drug, delaying purchasing decisions due to concerns about its high cost and efficacy in treating the disease.
In the latest release, the Centers for Medicaid and Medicare (CMS) officials said that Aduhelm was responsible for roughly half of the 14.5% increase in Part B premiums even as the Federal Government cited “uncertainty” about how much it may be forced to pay for the costly and controversial new Alzheimer’s drug.
Biogen reported US$300,000 in third-quarter sales for the drug, far short of analysts’ expectations of US$10 million. However, the company stated that it still believed in the treatment’s long-term potential.
Biogen is required to conduct a confirmatory trial to confirm the drug’s benefit under the terms of its US approval, a process that could take years. In the meantime, the drug may be marketed.
According to RBC Capital Markets analyst Brian Abrahams, a loss of European sales would effectively wipe out 40% of potential future Aduhelm revenue.
Only one of Biogen’s two pivotal trials demonstrated that Aduhelm can slow the rate of cognitive decline in Alzheimer’s patients, and the FDA’s decision to approve the drug was highly contentious.
Some members of a U.S. regulator’s advisory panel resigned in protest, and several prominent treatment centers have publicly stated that they will not prescribe Aduhelm to patients.