In June this year, we saw U.S regulators finally approve Biogen’s newest drug, “Abuhelm”.
It could be the first treatment for the root cause of Alzheimer’s disease. Importantly, this represents the first approval of an Alzheimer’s drug in almost 20 years.
While the FDA has previously approved Alzheimer’s drugs, these were aimed at symptom containment, not to slow the disease itself. This is truly ground-breaking.
Rewind to October 2019 when the initial approval was granted, we witnessed Jim Cramer (love him or loathe him) and David Faber (CNBC anchor) discuss the implications live on air:
Key takeaways
- An incredible 6.2 million American’s live with Alzheimer’s disease, and Biogen’s drug represents the first actual treatment of the disease, ever.
- However, perhaps even more interesting is the FDA’s more constructive demeanour.
- Biotech firms have focused on C-19 Vaccines, slowing FDA activity. But now, they’re back and at a pivotal moment.
David Faber: “You tell me about just how big this drug approval is?”
Jim Cramer “How about it being the biggest ever?”
David Faber “Yes it would”
Back to today and following on from the FDA’s Biogen approval, we’ve seen both Eli Lilly and Roche conducting their own phase III clinical trials for Alzheimer’s treatments. The FDA recently awarded breakthrough therapy designation to two other possible Alzheimer’s therapies that use similar methods as Aduhelm. This means the FDA will likely approve these therapies in the next few years.
Further, the FDA’s decision to green-light these treatments has created significant hope for the large global population of Alzheimer’s sufferers. An easier, more constructive FDA could and should have profound constructive implications for the entire industry, as the regulator’s willingness to approve more treatments provides potentially significant investment opportunities going forward. Back to Jim:
Jim Cramer “More importantly this tells me that the FDA will be fast-tracking many more drugs”
Jim Cramer “It’s a brand new FDA”
Jim Cramer “The FDA has gotten easier!”
Share