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FDA approves ALS drug amid controversial data and pricing

Health reporter Anjalee Khemlani outlines the circumstances behind the FDA's approval of a new ALS treatment drug amid high drug prices.

Video Transcript

DAVE BRIGGS: Hopes are rising for thousands of ALS sufferers and their families across the country. The FDA approving a new treatment for ALS, also known as Lou Gehrig's disease. Anjalee Khemlani is here with that story. Anj, this is interesting because it's a lot like Aduhelm with Alzheimer's most recently. There is some controversy, though it appears to be very good news.

ANJALEE KHEMLANI: That is correct, Dave. So while we do have the good news of the approval and some positive data from the trials that have been conducted to date, they did get a little bit of leniency, this company, from the FDA when they committed, or said, rather, during the FDA meeting that they would continue that third phase, that phase III trial. And if things failed in that phase III trial, they volunteer to pull it off the shelves then.

But later on, we heard in reports that they basically pulled back on that commitment, saying that phase III trial is not binding essentially. It's not confirmatory in the US. So there really is some concern about what that means. We know that this drug, of course, as you mentioned, helps 30,000 patients potentially elongate the value of their lives. And that's really how companies look at these drugs.

And that's why the pricing itself is another additional point of controversy for this drug, priced at around 12,500 per month, totaling about 158,000 a year. And some are saying that's a little too high. Even though it's lower than some competitors, it is a little too high, considering the fact that if you remember the ice bucket challenge back in 2015, that raising funds from there helped to contribute to the funding of this treatment.

And so that is where some concerns are coming from. There's a lot more, I guess, accountability being asked for, considering how many more people are involved, how many more stakeholders, you could say, there are as part of this, compared to when the drug is just funded by the company itself.

DAVE BRIGGS: Yeah, nice to see it getting some attention, nonetheless, but surprising to see shares down almost 7%, AMLX. Anjalee Khemlani, thanks so much. Enjoy the weekend.