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Walgreens' Ray Tancredi Discusses Alzheimer Drugs in the Pipeline and Lessons From Aduhelm
The approval of aducanumab (Aduhelm) was very controversial. There are 3 promising Alzheimer disease drugs in the pipeline with trials evaluating the efficacy, and there is a huge unmet need for these therapies, said Ray Tancredi, RPh, MBA, CSP, divisional vice president, specialty pharmacy development and brand Rx/vaccine purchasing, Walgreens.
The approval of aducanumab (Aduhelm) was very controversial. There are 3 promising Alzheimer disease drugs in the pipeline with trials evaluating the efficacy, and there is a huge unmet need for these therapies, said Ray Tancredi, RPh, MBA, CSP, divisional vice president, specialty pharmacy development and brand Rx/vaccine purchasing, Walgreens.
Transcript
Are there lessons learned from the aducanumab approval for the other Alzheimer disease drugs in the pipeline to keep in mind?
I think the one lesson that we have to learn is that [we have to] ensure that these products have been proven clinically to be efficacious. There's 3 drugs in the pipeline short term: you got Eli Lily with donanemab, you’ve got Eisai with lecanemab, and Roche with gantenerumab. And all 3 of these products could come to market. I think they're in clinical trials right now. Some of them look very promising in their use with mild cognitive impairment and early onset Alzheimer's. Then you look back at Aduhelm, which is aducanumab of Biogen; it was approved last year. Patients were very excited. It was through an accelerated pathway. And really, it's a serious condition that was really an unmet need.
But the approval—you know, we've all seen in the news—was very controversial. A number of the FDA advisory panels voted against the product, because there was insufficient evidence to show there was a clinical support for patients. And I think the CMS, in April of this year, of 2022, even had some coverage restrictions for the product.
So, I believe the products in the pipeline, as they evaluate their clinical trials, will ensure that they can prove efficacy, because there really is an unmet need. Patient advocacy, patients, caregivers really look forward to these products being approved and being effective in the marketplace.
I think some of the controversies around the approval of Aduhelm makes us maybe even step back and look at the approval process, the input and impact of approving these products, perhaps maybe a little bit too soon. But, you know, from my opinion, it's great to get these products in the market. Patients need them. And, you know, I believe that the 3 drugs that are in the pipeline, if they're approved will be approved in an appropriate manner and with efficacy intact. So, I do believe the FDA will continue to approve these products.
