Biogen (BIIB -0.80%) will get a decision on Alzheimer's disease drug aducanumab next month, but a recent op-ed by members of the Food and Drug Administration (FDA) advisory committee that reviewed came down hard against an approval. In this video from Motley Fool Live, recorded on April 5, Fool.com contributors Brian Orelli and Keith Speights discuss the unusual move by the advisory committee members and what it could mean for aducanumab even if the FDA approves the drug.
Brian Orelli: The FDA decision on Biogen's Alzheimer's drug aducanumab was supposed to be March 7, but the FDA, the FDA delayed it a couple of months ago to June 7. In November, the advisory committee voted with eight no votes and one yes vote and two abstentions that the one positive phase 3 clinical trial wasn't enough to support approval.
Usually, that's sort of the end of it for advisory committees and the FDA goes off and makes a decision. But now, three members of the committee have written an op-ed calling on the FDA to reject the drug. Is this bad news for Biogen, and do you think the members will have more influence on the FDA with this op-ed than they did at the committee meeting?
Keith Speights: First of all, it's absolutely bad news for Biogen. This is unusual. I think you might even say it's unprecedented, or at least as far as I recall, it's unprecedented for FDA advisory committee members to take such a public stance and write an op-ed to push the FDA not to approve a drug. This is not what usually happens at all. I think it's definitely bad news for Biogen. I think this puts a lot of pressure on the FDA, especially considering that this op-ed refers specifically to maybe the FDA being a little too cozy with Biogen and the process of getting the NDA for this Alzheimer's drug prepared.
Look, I think we're going to have to wait and see what happens. But if the FDA actually approves this drug, I think it's going to set off an absolute firestorm of controversy. Because if you read what these three members of the committee wrote in their op-ed and if you look at how the committee voted and why they voted in the way they did, they have some good reasons for not wanting this drug to be approved right now. They think an additional clinical study is warranted.
Orelli: The other thing is that these are really big key opinion leaders, and so even if the FDA does improve it, how many doctors are going to actually use the drug if the key opinion leaders in the space are saying, "We don't know if this drug actually works"?
Speights: Yeah. Maybe the even bigger factor there, Brian, is, how many insurance companies will say we're not going to approve it.
Orelli: Very good point.
Speights: Yeah. Even if a drug wins FDA approval, insurance companies don't have to cover the drug, and sometimes they don't. Sometimes they refuse to pay for drugs that have received FDA approval because they're not convinced the drugs are effective. If that happens, Biogen will really have some difficulties on its hands. Now, I'm not saying that's going to happen. It might not happen, but it could.