Last year, the FDA approved aducanumab, marketed as Aduhelm, a controversial drug made by Biogen and its Japanese partner Eisai to treat Alzheimer's. Things didn't go well, though, with expert opposition to the costly medication and a final death blow to its place in the market after Medicare limited coverage for it. On Tuesday, however, there was some more "upbeat news" from the drug's makers, per the Washington Post: A new experimental drug, lecanemab, slowed cognitive and functional decline in patients by 27%, as compared with patients who received a placebo, Biogen and Eisai announced in a release.
The trial involved 1,800 or so patients with mild cognitive impairment or mild Alzheimer's disease who started seeing results about six months after they started taking the medication, per the New York Times. These results, which haven't yet been peer reviewed, are "highly statistically significant," per the companies' release, and up the treatment's odds of getting the FDA's OK as early as next year. Shares for both Biogen and Eisai surged Wednesday—50% and 17%, respectively—in early trading on the news, as did those for rivals Roche and Eli Lilly, reports Reuters.
Similar to aducanumab, lecanemab decreases abnormal clumps of the beta-amyloid protein, which is considered to be an Alzheimer's marker. Unlike aducanumab, however, these trials for lecanemab were "completed according to protocol" and show that "lowering amyloid at this stage can translate into a slowing of clinical decline," neurologist Gil Rabinovici of the University of California-San Francisco tells the Post. He calls the trials a "huge breakthrough" and notes that that slowdown could prove "very meaningful" to those with the disease.
Some experts, however, want more data and are advising to proceed cautiously, especially after the Aduhelm debacle. Dr. Lon Schneider, who heads up USC's California Alzheimer's Disease Center, tells the Times he considers lecanemab's effect "small" and one that "would not be considered by many as a minimally clinically important difference," though he concedes there's industry disagreement on what's considered "clinically meaningful." Biogen and Eisai have applied for accelerated approval for the drug, with a Jan. 6 deadline for the FDA, but Eisai officials say they're also going to seek full approval, as that would up the chances that Medicare and other insurers would cover it. (Read more Alzheimer's disease stories.)