NEW YORK/TOKYO -- The new Alzheimer's disease treatment developed by Tokyo-based Eisai and American partner Biogen has divided the U.S. medical community since its controversial approval in June, leading to slow initial sales for a drug viewed as a potential blockbuster.
Early uptake of aducanumab has been "a bit slower than what we assumed," Biogen CEO Michel Vounatsos said on an earnings call in July, about a month after approval.
Sales through the end of June came in below market expectations at $1.6 million. Much of this went to pharmacy inventories, according to a Biogen executive, meaning that only a portion was actually given to patients.
Many major medical institutions declined to adopt the drug amid questions about the drug's effectiveness.
Aducanumab, marketed as Aduhelm, is the first new medication approved in roughly two decades for Alzheimer's, which has no effective treatment. More than 6 million Americans have the disease, and patients' advocacy groups have vigorously lobbied for the drug's approval. An Alzheimer's specialist reported being flooded with calls from eager patients about aducanumab's approval.
But the medical community is divided. The Alzheimer's Association has called the approval of aducanumab a "beginning of a completely new future for Alzheimer's treatments," while the American Neurological Association argued that approval was not merited under the current circumstances.
Biogen had been ready for a speedy launch, expecting around 900 medical centers in the U.S. to begin administering the drug relatively quickly after approval. But fewer than 40% actually gave the go-ahead to start in the first month. Many institutions saw a need to run their own safety and effectiveness reviews first, leading to delays.
The Food and Drug Administration's approval has met with fierce criticism.
There was debate from the review stage about whether aducanumab's benefits were worth the risks, and the committee that advised the FDA on the drug recommended against its approval, citing insufficient evidence of its benefits. When the agency cleared aducanumab on the condition that the drugmaker submit further trial data, multiple committee members quit in protest.
Interim FDA Commissioner Janet Woodcock's call on July 9 for an independent investigation into the approval process was decisive for many medical institutions to hold off on adopting the drug.
New York's Mount Sinai Health System, the Cleveland Clinic in Ohio, and Providence in Washington state, which together operate more than 70 hospitals, all said in July that they would not administer it. The Department of Veterans Affairs, which provides care to 9 million enrolled veterans, said this month that it would not include aducanumab on its formulary at this time.
Though views are divided on the approval process, hopes are high that this precedent will give drug development and usage a shot in the arm.
"There were also mixed views when our multiple sclerosis drug came out, but as time went on, its effectiveness became understood more widely, and it saw more use," said Teiji Kimura, chief discovery officer of Eisai's neurology business group. "This time is similar. I think the FDA made a thoughtful decision."
Eli Lilly looks to get a similar treatment approved this year.
A key question for aducanumab's future success will be how it is handled by Medicare, the government health program for older Americans, which many private insurers use as a guide. Aducanumab's list price of $56,000 a year is likely to put off many patients if it is not covered by insurance.
But the outlook for Medicare approval is unclear, a Biogen insider said. The source expressed hope for speedy decisions on insurance coverage, before mild cases that aducanumab could help progress too far.