Alzheimer’s Drug Lecanemab Could Get FDA Accelerated Approval This Week
The clock is ticking: As more than 6.5 million Americans live with dementia caused by Alzheimer’s, researchers and scientists are scrambling to develop a drug that slows cognitive decline. One such drug, lecanemab, could receive accelerated approval from the U.S. Food and Drug Administration on Jan. 6.
The news comes after the highly publicized debacle surrounding another experimental drug, Aduhelm (generic name: aducanumab). Incidentally, lecanemab and aducanumab both come from pharmaceutical giants Biogen and Eisai. Read here about what happened with aducanumab; the hope, of course, is that the lecanemab process does not repeat the “rife…irregularities” surrounding the $56,000-per-year Aduhelm. Biogen and Eisai have not revealed the price tag for lecanemab (and cost was only one point of contention regarding the approval of aducanumab).
Lecanemab is Still Experimental
Like Aduhelm, lecanemab qualifies as an experimental dementia drug. It appears to slow the progression of cognitive decline by binding to amyloid beta, an indicator of Alzheimer’s disease. (Note that there is debate as to whether the beta-amyloid protein causes Alzheimer’s.)
However, also like aducanumab, lecanemab does come with some safety concerns. Some patients in trials have experienced problems including brain swelling and bleeding. Overall, 14% of the lecanemab group reported serious adverse events, compared to 11.3% in the placebo group.
Even so, the companies behind lecanemab have been pushing for accelerated approvals from the FDA. If that happens, patients could start the drug even as scientists continue to study it in larger, longer trials.
Alzheimer’s Association Supports Lecanemab Approval
The Alzheimer’s Association supports the efforts. Here’s what the organization’s Maria Carrillo, chief science officer, told CNN:
“We believe, based on the totality of positive data from clinical trials of this treatment, that the FDA should approve. Peer-reviewed, published results show lecanemab will provide patients in the earliest stages of Alzheimer’s more time to participate in daily life and live independently. It could mean many months more of recognizing their spouse, children, and grandchildren.”
As such, the Alzheimer’s Association is asking the Centers for Medicare and Medicaid Services to cover lecanemab. Right now, CMS blocks access to the treatment.
What Might Be Next for Lecanemab?
Again, if the FDA does grant accelerated approval this week, lecanemab will undergo more trials. If those studies confirm clinic benefit, then lecanemab could receive traditional FDA approval. But if those trials show more harm than good, then the FDA would likely take lecanemab off the market.
Clinicians would probably take time to determine how effective lecanemab might be for their patients. Drugs come with risk and doctors have to assess benefit versus drawback for each individual they treat.