Before Biogen scored an FDA approval for Alzheimer's drug Aduhelm, the company probably hoped its launch would go much smoother than the last three months have been. It turns out Biogen's CEO Michel Vounatsos is willing to say so publicly.
Speaking at a Morgan Stanley healthcare event Thursday, Vounatsos said there's "clearly too much confusion, misinformation and controversy surrounding our data and the approval process." The launch has been "even more gradual than we had expected," he added.
The company is facing "near-term challenges," Vounatsos told the virtual audience, noting that "everybody can see that." Now, months after the drug's approval, he said it's "imperative" that "society moves its attention [from] the clinical data to the patients in need."
After Aduhelm's accelerated approval in June, a firestorm quickly engulfed the new Alzheimer's drug. Lawmakers and medical experts have questioned the data Biogen used to support an approval plus the FDA's procedures that led to the accelerated nod.
The criticism grew so intense that the FDA and Biogen, in an unusual move, walked back Aduhelm's broad label just weeks into the launch. The FDA originally endorsed the drug for all Alzheimer's patients but later restricted the label to those with mild cognitive impairment or mild dementia.
In another big setback for the rollout, the Department of Veteran's Affairs last month decided against covering the drug, citing a "risk of significant adverse drug events" and a "lack of evidence of a positive impact on cognition."
Looking forward, one key question mark for the rollout remains in the Centers for Medicare & Medicaid Services' coverage decision on the drug. That's expected in January and will determine whether federal insurance programs get behind the treatment.
Meanwhile, the company is working to improve the public's understanding of the clinical data and on generating additional data, Vounatsos said. It's also aiming to bring more treatment centers online and negotiate reimbursement deals to "maximize access," he added.
Biogen's drug launched with big sales expectations, but its initial stumbles have dampened some of the enthusiasm on Wall Street. In a note about Vounatsos' Thursday presentation, Jefferies analysts said the Street is "very negative on the early launch." Analysts still expect the drug to bring in multiple billions of dollars per year once it gets rolling.