Health
FDA approves drug to slowly slow progression of Alzheimer's disease
US authorities have approved another drug that can slightly slow the progression of Alzheimer's disease, providing a new option for patients who are in the early stages of the incurable, memory-destroying disease. The US Food and Drug Administration on Tuesday approved Eli Lilly's Xanla for the treatment of mild or early dementia due to Alzheimer's disease. It is the second drug to be reliably shown to slow cognitive decline in patients, following a similar drug from Japanese drugmaker Eisai approved last year. The delay seen with both drugs ranges from several months, but with Lilly's drug, it is about seven months. Patients and their families will have to weigh the benefits against the drawbacks, such as regular infusions and potentially dangerous side effects like brain swelling. Doctors who treat Alzheimer's say the approval is an important step after decades of failed treatments. “We're thrilled that we have a range of options to help patients,” said Dr. Suzanne Schindler, a neurologist at Washington University in St. Louis. “As a dementia specialist, it's difficult. You diagnose a patient with Alzheimer's and then watch them get worse every year until they pass away.” Both Kisunra and the Japanese drug, Lukembi, are lab-made antibodies administered by infusion that target the buildup of sticky amyloid plaques in the brain, one of the causes of Alzheimer's. Questions remain about which patients should receive these drugs and for how long they will be effective. The new drug was expected to be approved after the FDA's panel of outside advisers voted unanimously in favor of its merits at a public meeting last month. The approval came despite several questions from FDA reviewers about how Lilly studied the drug, including whether it allowed patients to stop treatment once plaques reached very low levels. The FDA approved Kisunra, known by the chemical name donanemab, based on the results of an 18-month study that showed that patients who received the treatment experienced about 22% slower declines in memory and cognition than those who received dummy infusions.The main safety issue is brain swelling and bleeding, a problem common to all drugs that target plaque. The rates reported in Lilly's study (including 20% of patients with microbleeds) were slightly higher than those reported with rival product Requembi. But experts say it's difficult to compare the safety of the drugs because the two drugs were tested on slightly different types of patients. Xanla is a monthly infusion, while Requembi is a twice-monthly dosing schedule, which could make it easier for caregivers who take loved ones to hospitals and clinics. “Obviously, a monthly infusion is more appealing than an infusion every two weeks,” Schindler said. Lilly's drug has another potential advantage: Patients can stop taking it if they respond well. In the company's study, patients stopped taking Xanla when their brain plaque reached low levels. More than 40% of patients stopped taking the drug after a year. Stopping the drug could reduce the cost and safety risks of long-term use. It's not yet clear when patients will need to resume infusions. Logistical hurdles, uneven insurance coverage and financial concerns have delayed the rollout of a competing product, Leqembi, which Eisai co-markets with its U.S. partner Biogen. Many smaller hospitals and health systems are not yet equipped to prescribe the new plaque-targeting Alzheimer's drugs. First, doctors need to confirm that dementia patients have the plaques that the new drugs target in their brains. Then they need to find drug infusion centers where patients can get the treatment. Meanwhile, nurses and other staff must be trained to do repeated scans to check for brain swelling or bleeding. “All of this is something doctors have to prepare for,” said Dr. Mark Mintang, head of Eli Lilly's neuroscience division. “Until doctors are comfortable with it, the treatment won't be offered to patients coming into the clinic.”
US regulators have approved a new drug that may slightly slow the progression of Alzheimer's disease, offering a new option for patients in the early stages of the incurable, memory-destroying illness.
The U.S. Food and Drug Administration on Tuesday approved Eli Lilly's Xanra to treat mild or early dementia caused by Alzheimer's disease, the second drug reliably shown to slow cognitive decline in patients. This follows approval of a similar drug by Japanese pharmaceutical company Eisai last year..
The delays for both drugs can last several months — about seven months for Lilly's — and patients and their families must weigh the benefits against the drawbacks, such as regular infusions and potentially dangerous side effects like brain swelling.
Doctors who treat Alzheimer's disease say the approval is an important step after decades of failed treatments.
“I'm thrilled that we have so many options to help patients,” said Dr. Suzanne Schindler, a neurologist at Washington University in St. Louis. “As a dementia specialist, it's difficult to diagnose a patient with Alzheimer's disease and then watch them get worse every year until they die.”
Kisunra and the Japanese drug Lukembi are both lab-made antibodies given by infusion that target the buildup of sticky amyloid plaques in the brain that contribute to Alzheimer's. Questions remain about which patients should receive the drugs and for how long they can be expected to work.
The drug's approval was expected after the FDA's panel of outside advisers voted unanimously in favor of its effectiveness at a public meeting last month. FDA reviewers had several questions about how Lilly studied the drug, including discontinuing treatment for patients whose plaque levels had reached very low levels, but the approval fell short.
The FDA approved Xanra, known by the chemical name donanemab, based on results from an 18-month study that showed that patients who received the treatment experienced about 22% slower decline in memory and cognition than those who received a dummy injection.
The main safety issue is brain swelling and bleeding, a problem common to all drugs that target plaque. The incidence reported in Lilly's trial (including 20% of patients with microbleeds) was slightly higher than that reported for rival Lukembi. But the two drugs were tested in slightly different types of patients, making it difficult to compare their safety, experts say.
Kisanra requires a monthly infusion compared with Lekumbi's twice-monthly dosing regimen, potentially reducing the burden on caregivers who must take loved ones to hospitals or clinics for treatment.
“Certainly, getting an infusion once a month is more attractive than getting an infusion every two weeks,” Schindler said.
Lilly's drug has another potential advantage: Patients can stop taking it if they respond well.
In the company's study, patients stopped taking Xanla once brain plaque levels reached low levels. After a year, more than 40% of patients had stopped taking the drug. Stopping the drug could reduce the costs and safety risks associated with long-term use. It's not yet clear when patients will need to start receiving the infusion again.
Logistical obstacles, inadequate insurance coverage and financial concerns have slowed the rollout of a competing drug, Lukenvi, which Eisai co-markets with U.S. partner Biogen, and many smaller hospitals and health systems are not yet ready to prescribe the new plaque-targeting Alzheimer's drug.
First, doctors need to confirm that dementia patients have brain plaques that can be targeted by new drugs, then they need to find infusion centers where patients can get the treatment, while nurses and other staff need to be trained to do repeated scans to check for brain swelling or bleeding.
“These are things that physicians need to be prepared for,” said Dr. Mark Mintan, head of Lilly's neuroscience division. “Until physicians are comfortable with these, they won't be offered to patients coming into their offices.”
|
Sources 2/ https://www.kcra.com/article/kisunla-alzheimers-drug-fda-approval/61488947 The mention sources can contact us to remove/changing this article |
What Are The Main Benefits Of Comparing Car Insurance Quotes Online
LOS ANGELES, CA / ACCESSWIRE / June 24, 2020, / Compare-autoinsurance.Org has launched a new blog post that presents the main benefits of comparing multiple car insurance quotes. For more info and free online quotes, please visit https://compare-autoinsurance.Org/the-advantages-of-comparing-prices-with-car-insurance-quotes-online/ The modern society has numerous technological advantages. One important advantage is the speed at which information is sent and received. With the help of the internet, the shopping habits of many persons have drastically changed. The car insurance industry hasn't remained untouched by these changes. On the internet, drivers can compare insurance prices and find out which sellers have the best offers. View photos The advantages of comparing online car insurance quotes are the following: Online quotes can be obtained from anywhere and at any time. Unlike physical insurance agencies, websites don't have a specific schedule and they are available at any time. Drivers that have busy working schedules, can compare quotes from anywhere and at any time, even at midnight. Multiple choices. Almost all insurance providers, no matter if they are well-known brands or just local insurers, have an online presence. Online quotes will allow policyholders the chance to discover multiple insurance companies and check their prices. Drivers are no longer required to get quotes from just a few known insurance companies. Also, local and regional insurers can provide lower insurance rates for the same services. Accurate insurance estimates. Online quotes can only be accurate if the customers provide accurate and real info about their car models and driving history. Lying about past driving incidents can make the price estimates to be lower, but when dealing with an insurance company lying to them is useless. Usually, insurance companies will do research about a potential customer before granting him coverage. Online quotes can be sorted easily. Although drivers are recommended to not choose a policy just based on its price, drivers can easily sort quotes by insurance price. Using brokerage websites will allow drivers to get quotes from multiple insurers, thus making the comparison faster and easier. For additional info, money-saving tips, and free car insurance quotes, visit https://compare-autoinsurance.Org/ Compare-autoinsurance.Org is an online provider of life, home, health, and auto insurance quotes. This website is unique because it does not simply stick to one kind of insurance provider, but brings the clients the best deals from many different online insurance carriers. In this way, clients have access to offers from multiple carriers all in one place: this website. On this site, customers have access to quotes for insurance plans from various agencies, such as local or nationwide agencies, brand names insurance companies, etc. "Online quotes can easily help drivers obtain better car insurance deals. All they have to do is to complete an online form with accurate and real info, then compare prices", said Russell Rabichev, Marketing Director of Internet Marketing Company. CONTACT: Company Name: Internet Marketing CompanyPerson for contact Name: Gurgu CPhone Number: (818) 359-3898Email: [email protected]: https://compare-autoinsurance.Org/ SOURCE: Compare-autoinsurance.Org View source version on accesswire.Com:https://www.Accesswire.Com/595055/What-Are-The-Main-Benefits-Of-Comparing-Car-Insurance-Quotes-Online View photos
to request, modification Contact us at Here or [email protected]
 |
 |
 |
