For the first time in 20 years, the Federal Drug Administration has approved a new drug to treat Alzheimer's disease.
The drug aducanumab, developed by Massachusetts biotechnology company Biogen, is the first approved drug that may slow the progression of Alzheimer's. Until now, all approved Alzheimer's drugs have only addressed the symptoms of the disease.
"I think to call it a historic development in the fight against Alzheimer's is not any sort of overstatement," said Lynn Mullowney Cabrera, executive director of Montana's Chapter of the American Alzheimer's Association. "This is the most meaningful piece of hope that millions of families have been waiting for, for years."
The drug will be marketed under the brand name "aduhelm." It is not a cure for Alzheimer's, but experts say even slowing the progression of the disease is significant.
"This is the first disease-modifying therapy for Alzheimer's patients that can actually change the trajectory of the disease," explained Dr. Charles Bernick, clinical trials director of UW Medicine's Memory and Brain Wellness Center. "It does not stop the disease progression, but it slows it down, perhaps 20 to 25 percent is what we've seen in the studies. Even that slowing of progression, if started early enough, has a huge impact on a disease that may last over twenty years."
Controversy is already swirling over the FDA's approval of the drug. Critics are calling for Congress to investigate Biogen's cozy relationship with the FDA, questioning why the agency ignored the recommendations of its own advisory committee.
"There is enough evidence, and I think the FDA felt so, that the drug should be allowed to be on the market," Dr. Bernick said. "The FDA felt the one thing the drug does, and I think everyone agrees upon, is that it removes the plaques, the amyloid plaques from the brain in people with Alzheimer's, and that's the signature pathology of the disease."
For more than 6 million Americans living with Alzheimers's today, the hope is that aduhelm will hasten the pace of discovery and innovation, leading to new treatments and eventually the world's first Alzheimer's survivor.
"We know those treatments that were initially introduced years ago to treat cancers, to treat HIV AIDS, those aren't what they are now," said Cabrera. "But it has to start somewhere. This is a critical jump start."
According to Cabrera, as many as 22,000 Montanans are currently living with Alzheimer's. The disease is now the sixth-leading cause of death in the U.S.
As for how soon aduhelm will be available to the general public, Biogen has yet to commit to a specific time frame. The answer to that question will come into better focus as the company ramps up production of the drug and doctors determine which patients would be the best fit for the new treatment.
The drugs's yearly cost is estimated at $56,000 per patient.