Eli Lilly on Monday said it applied for full U.S. Food and Drug Administration approval of its Alzheimer’s treatment, donanemab, and expects the agency to make a choice by the tip of the yr.
The appliance relies on positive phase three clinical trial results on donanemab, which significantly slowed the progression of Alzheimer’s in patients on the early stages of the mind-robbing disease.
The outcomes also showed that treating patients who’re on the earliest stages of the disease can slow Alzheimer’s progression by around 40% to 60%.
“The sooner you start to make use of the drug perhaps the more slowing that may be,” Eli Lilly CEO David Ricks said in an interview Monday on CNBC’s “Squawk on the Street.”
Eli Lilly is among the many pharmaceutical corporations racing to market latest treatments for the disease after Eisai and Biogen’s drug Leqembi won FDA approval this month. The agency’s signoff on Leqembi was a milestone within the treatment of Alzheimer’s, despite the fact that the drug and donanemab aren’t cures.
Each treatments are monoclonal antibodies that focus on amyloid plaque within the brain, considered a trademark of the disease.
An FDA approval of Eli Lilly’s donanemab would expand the treatment options for the greater than 6 million Americans of all ages who’ve Alzheimer’s, the fifth-leading reason behind death for adults over 65.
The corporate didn’t disclose how it will price donanemab after a possible approval.
However the Centers for Medicare & Medicaid Services has said Medicare will cover Alzheimer’s drugs – so long as they receive full FDA approval and health-care providers take part in a registry system that collects data on how the drugs work in the actual world.
Ricks said the registry requirement appears to be a “pretty light touch” that does not “take a variety of effort.” But he noted that the information that can be collected seems “pretty low value” in the method.
“So we hope to have that [requirement] rescinded in time and full coverage for donanemab when it’s approved,” Ricks told CNBC.
Positive trial results for Lilly’s Alzheimer’s treatment
Eli Lilly on Monday also presented the ultimate results from the 18-month phase three trial of the monthly antibody infusion donanemab on the Alzheimer’s Association International Conference in Amsterdam. The outcomes confirm the initial data the corporate released in early May.
The ultimate results also address a previous concern of the FDA, which rejected Eli Lilly’s application for expedited approval of donanemab in January. On the time, the agency asked the corporate for more data on patients who received the treatment for a minimum of 12 months.
Eli Lilly and Company, Pharmaceutical company headquarters in Alcobendas, Madrid, Spain.
Cristina Arias | Cover | Getty Images
The trial followed greater than 1,700 patients within the early stages of Alzheimer’s who had a confirmed presence of amyloid plaque. Roughly half of participants received donanemab.
Patients who received donanemab demonstrated a 35% slower decline in memory, considering and their ability to perform each day activities at 76 weeks — roughly a yr and a half of treatment — compared with those that received a placebo.
Patients on the earliest stage of the disease had a greater profit after taking donanemab, demonstrating a 60% slower decline in cognitive function.
The trial also found that patients who took donanemab were almost 39% less more likely to progress to the subsequent stage of Alzheimer’s disease.
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Almost half of patients – 47% – who received donanemab showed no disease progression a yr after treatment began, in keeping with the ultimate trial results. That compares with 29% for individuals who didn’t receive the drug.
The Alzheimer’s Association, a corporation that advocates for individuals who have the disease, said it “strongly supports” FDA approval of donanemab based on the positive results.
“The outcomes illustrate that initiating treatment as early as possible enables the potential for a much bigger helpful effect, but in addition that there may be potential for slowing of disease progression even when treatment is began later within the disease progression,” said Maria Carrillo, chief science officer of the Alzheimer’s Association, in a press release.
Advantages and negative effects of donanemab
Greater than half of patients accomplished the treatment in the primary yr, and 72% accomplished it in 18 months on account of clearance of amyloid plaque.
The Alzheimer’s Association said that data point is “notable for patients, families, prescribers and payers because patients may not have to receive this treatment on an ongoing basis for the remaining of their lives.”
Donanemab cleared amyloid plaque at six months in 34% of patients who had intermediate levels of a protein called tau, which might grow to be toxic and kill neurons.
At 76 weeks, donanemab cleared the plaque in about 80% of patients with the identical tau levels. That compares with 0% plaque clearance amongst those that took the placebo over the identical time period.
But donanemab’s advantages can have to be weighed against the risks.
Drugs that focus on and clear amyloid plaque may cause brain swelling and bleeding in patients that in some cases may be severe and even fatal.
The trial results said nearly 37% of individuals on donanemab had these negative effects, called amyloid-related imaging abnormalities, compared with nearly 15% who received a placebo. Three trial participants died from those negative effects, in keeping with Lilly.
Those negative effects have also been observed in Leqembi.