FDA rejects Eli Lilly’s accelerated approval application for Alzheimer’s drug
Yahoo Finance Live anchors discuss the move lower in Eli Lilly stock.
Video Transcript
- Eli Lilly, shares of the drug maker sinking today as the FDA declined to grant accelerated approval to its experimental Alzheimer's drug Donanemab. The FDA rejecting the application because it needed data from at least 100 patients taking that drug for at least one year. Now, Lilly says many had to stop taking the drug after six months due to the speed of the plaque reduction. So maybe we're too fast is what they're saying.
The company plans to file phase III clinical trial data later this year for a traditional FDA approval. More than 6 million Americans are suffering with Alzheimer's today. Dr. Howard Philip of the Alzheimer's Drug Discovery Foundation telling me, quote, amyloid clearing drugs such as these are one part of the solution. But there remains a pressing need to develop a new generation of drugs targeting all aspects of the biology of aging.
Shares of Lilly down about 1 and 1/2% today. They were far worse shape earlier in the day, down more than 3%. They have rallied as we've gotten closer to the close. Still up more than 40% over the last 12 months. This has been a real area of focus for big pharma. Needless to say because of how difficult, how painful it is, and how many Americans suffer through it, it's been a controversial process given the FDA approval process and the extreme cost of these drugs.
- Yeah. Certainly. And there certainly has been a race here to try to find some sort of treatment in this space. When you take into account all of the drugs, all the treatments that are under consideration-- this is according to the Alzheimer's Association-- this is just one of more than 300 treatments that are in clinical trials. So, hopefully, we will continue to get positive results. And it also seems like Eli Lilly still remains pretty upbeat in terms of what we could see at the future trials that we will get from this drug.
Taking a look out, though, what this could mean for some of the competitors out there, we know Biogen has an Alzheimer's treatment that William Blair was out with a note saying that it could actually be a positive here for that company, just an investment angle, putting aside the human angle here for a second. Just taking a look at Biogen, though, that stock actually ticking to the upside today on the heels of this news. But certainly more treatments are needed within Alzheimer's. And when you take into account all the clinical trials that are currently underway, hopefully we will start getting positive results, more positive results in the future.
- It is such a painful process to watch as someone who has had to suffer through it. Let's hope this race is won soon. Josh Schafer, thanks for playing.
