A key European Medicines Agency panel has signalled it is unlikely to grant approval to Biogen's drug for Alzheimer's disease, adding to the debate surrounding a controversial treatment that retails at $56,000 (€49,500) a year.
On Wednesday, Biogen said the drug it has developed with Japan's Eisai, Aduhelm, received a "negative trend vote" from the Committee for the Medicinal Products for Human Use panel on its application for marketing authorisation in the bloc. The panel is expected to give its formal decision next month, Biogen said.
New York-listed shares in the drugmaker were down as much as 4.3 per cent before partially paring back losses to 2.7 per cent in morning trading.
Priya Singhal, the head of global safety and regulatory sciences at the company, said Biogen was "disappointed" with the vote, but that it "strongly believe[d] in the strength of our data" and the drug's ability to make a difference for Alzheimer's patients.
The EMA did not immediately respond to a request for comment. Biogen said it would continue to engage with the agency as it “considers next steps”.
The drug, which is given as an infusion, was approved by US regulators in June, becoming the first new treatment for Alzheimer’s in almost two decades that purports to slow the development of the neurological disease.
Biogen has said it hopes the treatment will become a blockbuster drug, capable of boosting the company’s revenue at a time when many of its existing products face competition. But Aduhelm’s approval in the US has provoked a wave of controversy, with some scientists arguing there is scant scientific evidence that it actually works.
In August the US health department’s inspector-general announced a review of the FDA’s accelerated approval process for drugs following the controversy over Aduhelm.
Slow to embrace
US healthcare providers and insurers have been slow to embrace the drug, delaying purchasing decisions amid concerns over its high cost and doubts over its efficacy in treating the disease. Biogen reported third-quarter sales of just $300,000 for the drug, falling far short of analysts’ expectations of $10 million. However, the company said it still believes in the long-term potential of the treatment.
Under the terms of its US approval, Biogen has to carry out a confirmatory trial to affirm the drug’s benefit, a process that could take years. It is allowed to market the drug in the meantime.
Alfred Sandrock, Biogen's head of research and development who led development of Aduhelm, announced his retirement on Tuesday.
Brian Abrahams, analyst at RBC Capital Markets, said given the mixed data on the drug it was not hugely surprising that the EMA panel did not endorse Aduhelm. He said Biogen could appeal the recommendation but successful appeals were rare – about one in five – and it now looked unlikely the drug would make it over the line in Europe with the existing data set. – Copyright The Financial Times Limited 2021
