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The approval this month of an Alzheimer's drug from biotech company Biogen (BIIB) — along with the treatment's eye-popping $56,000 per year price tag — set off a wave of criticism over scant evidence that the drug slows one of the disease's most debilitating symptoms: cognitive decline.
In a new interview, David Ricks — CEO of rival pharmaceutical company Eli Lilly (LLY) — added his voice to those surprised by the Food and Drug Administration's (FDA) decision to approve the drug.
Ricks called the approval "surprising," describing the treatment's trial data as "pretty controversial." The decision from the FDA demonstrates a shift in "the bar" for Alzheimer's drug approvals that will spur investment in drugs from other companies seeking the same green light, Ricks told Yahoo Finance.
"We're still kind of processing what occurred," says Ricks, whose company is also developing an Alzheimer's drug and saw a stock bump after the approval. "I think it was surprising for a lot of people."
Two trials of Biogen's drug, Aduhelm, showed that it reduces amyloid-protein plaques in the brain that are associated with Alzheimer's and the cognitive decline it induces. But in one trial the drug showed no alleviation of cognitive decline, and in the other it showed a minor effect on such decline that barely exceeded that produced by a placebo, the New Yorker reported.
Biogen initially scrapped the trials but later revisited them and found encouraging results, in part due to the inclusion of patients who finished the trial in the period after it had been abandoned.
"The data set itself was pretty controversial," Ricks says. "This happens in medical research, where the gold standard for approval is you call your shot, and then you hit your shot, like Babe Ruth pointing at the left field and then hitting his home run there."
"Here, something different happened, and this happens pretty frequently in medical development," he adds. "Where they call their shot, and then they ended up stopping a study and then looking back and seeing something more encouraging."
"That's not a normal process," he says. "And having worked ourselves in Alzheimers for the last 34 years, and we've had lots of failures, too. And on look back, sometimes you become encouraged. But really, it's important that I think drug companies generate very solid evidence for the use of our products."
The approval marks a newfound willingness from the FDA to give the go-ahead for Alzheimer's drugs that address biological signs of the disease even if they don't show efficacy treating the underlying disease itself, Ricks said.
"The FDA actually in the end did not say that those results were solid evidence, what they said was that the drug moves what's known as a biomarker or a precursor to the disease in a very meaningful way, which I think is without dispute," Ricks says.
"But then [the FDA] said that that biomarker or precursor is enough for approval, so in a way sort of shifting the bar or the policy for Alzheimer's approvals," he adds.
'There are huge unmet needs'
Biogen's drug is delivered through multiple intravenous injections, likely requiring visits with a physician. For his part, Biogen CEO Michel Vounatsos celebrated the approval and expressed confidence that the drug will help Alzheimer's patients.
"We believe this first-in-class medicine will transform the treatment of people living with Alzheimer’s disease and spark continuous innovation in the years to come," he told USA Today. "We are grateful for the contributions of thousands of patients and caregivers who participated in our clinical trials, as well as for the dedication of our scientists and researchers."
The backlash against the approval escalated last week with the resignation of three scientists who served on a committee that advised the Food and Drug Administration (FDA) on the treatment. One of the scientists, Harvard Medical School professor Aaron Kesselheim, told The New York Times it "might be the worst approval decision that the F.D.A. has made that I can remember."
Speaking to Yahoo Finance, Ricks said the approval does offer some hope for over 6 million people living with Alzheimer's, and will incentivize other companies to pursue therapies for the disease.
"We know there are huge unmet needs," Ricks says. "So in some sense, that's a hope for patients."
"I think it will also unleash a lot of investment from companies to prove the same thing with other drugs because it is an easier task," he adds.
Clarification: This article was clarified to indicate that Ricks is surprised by the FDA's approval of the Alzheimer's drug rather than skeptical of the approval.