On July 9, the FDA approved donanemab, a monoclonal antibody that slows the progression of early Alzheimer’s disease. CNN reports:
Donanemab, made by Indianapolis-based Eli Lilly, works by helping the body remove amyloid plaque buildup in the brain, a hallmark of Alzheimer’s disease. Lilly said it will be sold under the name Kisunla and would cost $695 per vial before insurance, what would amount to $12,522 for a six-month course or about $32,000 for a year, depending on when the patient would complete their treatment. Donanemab is not a cure, but clinical trials showed that it slowed the progression of Alzheimer’s, allowing people to live independent lives for longer and safely participate in everyday activities….
Lilly told a committee of FDA advisers in June that late-stage clinical research data showed “highly meaningful results” for people who took donanemab, with about 35% lower risk of progression of the disease over a year and a half compared with those who got a placebo. The FDA advisers voted that the treatment appeared safe and effective.
One in three older Americans dies with Alzheimer’s disease or another form of dementia, according to the Alzheimer’s Association, killing more people than prostate and breast cancer combined…The number of people projected to have Alzheimer’s is predicted to grow to nearly 14 million by 2060, according to the US Centers for Disease Control and Prevention. As of 2023, about 6.7 million Americans 65 and older live with Alzheimer’s….More than 11 million family members and unpaid caregivers provided an estimated 18 billion hours of care to people with Alzheimer’s and other dementias in 2022 alone…there has been an ongoing shortage of paid workers and medical professionals.
Brain implants are now being used to restore cognitive abilities wiped out by traumatic brain injuries, enabling people to work again, and do things they previously couldn’t do because of their brain injury, such as reading, avoiding getting speeding tickets, and grocery shopping.
The world’s first anti-epilepsy device has been fitted into a boy’s skull.
Skull implants could also fight depression. A child has been cured of a type of brain cancer that previously always killed people who had it. Earlier, a blood test was developed that detects many brain cancers that doctors previously couldn’t detect until it is too late to save most victims.
Scientists have also come up with personalized cancer vaccines that cut death rates from melanoma and breast cancer by 40-50%, but regulatory approval will likely take years.
In other news, a new blood test can detect which bowel cancer patients can receive a lifesaving immunotherapy rather than chemotherapy, enabling them to be cancer free after surgery. Around 10-15% of patients with stage two or three bowel cancer have a particular genetic make-up that enables them to benefit from the life-saving immunotherapy known as pembrolizumab.
Even if these medical advances save countless lives, government regulations may delay them from being used for years. The FDA can take years to approve vaccines, medical tests, and drugs. The FDA didn’t approve a home test for HIV until 24 years after it first received an application. According to an FDA advisory committee, the test held “the potential to prevent the transmission of more than 4,000 new HIV infections in its first year of use alone.” That means thousands of people likely got infected with AIDS as a result of the delay in approving it. At least a hundred thousand people died waiting years for the FDA to approve beta blockers.
Scientists have developed tiny robots made of human cells to repair damaged cells. And Arizona State University scientists “have successfully programmed nanorobots to shrink tumors by cutting off their blood supply,” fighting cancer.
