Hope is not a reason to approve a drug

GOOD MORNING: The future of Biogen’s potential blockbuster Alzheimer’s treatment was thrown back into doubt on Friday when an unusually combative scientific panel contradicted the positive conclusions of staff at the US drug regulator. This drug may be nothing but a lifesaver to Alzheimer’s patients.

More than 5 million Americans of all ages have Alzheimer’s. An estimated 5.8 million Americans age 65 and older are living with Alzheimer’s dementia in 2020. Eighty percent are age 75 or older. One in 10 people age 65 and older (10%) has Alzheimer’s dementia. It’s a horrible disease whose cure has baffled pharma R&D people.

Just two days ago, Biogen shares soared 44 percent when the Food and Drug Administration’s own scientists said there was “substantial evidence” that aducanumab was effective. However, many scientists derided the trial data as incomplete and inadequate, and some rounded on the regulator for pushing forward with the approval process. In an 8-1 vote, the panel said Biogen’s late-stage study didn’t provide “strong evidence” showing that aducanumab effectively treated Alzheimer’s. Two other panelists said it the data was “uncertain.”

Wall Street firms didn’t mince words about the panel’s findings, which was that data from a single clinical trial with positive results was insufficient to show the treatment worked. Raymond James called it a “disaster,” while Baird wrote that the panelists had “skewered the company.” An approval of the treatment, called aducanumab, is now “virtually impossible,” it added.

Evidently the FDA panel did not find Biogen’s recut data a reason to believe that this drug should be approved. If this drug had been approved there is not doubt that Medicare patients would have shouldered most of the cost but the real question to ask is “how much does hope cost?”.

Biogen is desperate for approval of this drug. Analysts now are listing this stock as “underperforming” and have issued warnings to investors. The FDA could still grant approval but they would be doing patients’ and caregivers’a huge disservice.