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Scientists tie third clinical trial death to experimental Alzheimer ’s drug
As enthusiasm mounts for a new experimental antibody that appears to slow cognitive decline in some Alzheimer’s patients, a third death linked to the drug during its clinical testing may amplify concerns about its safety. Science has obtained medical records showing a 79-year-old Florida woman participating in an ongoing trial of the antibody died in mid-September after experiencing extensive brain swelling and bleeding, as well as seizures. Multiple neuroscientists who reviewed the records at Science ’s request believe her death was likely caused by the antibody, lecanemab. “The brain swelling and t...
Source: ScienceNOW - December 21, 2022 Category: Science Source Type: news

As some hail new antibody treatment for Alzheimer ’s, safety and benefit questions persist
In a packed San Francisco conference room with a celebratory atmosphere, upbeat company representatives and scientists yesterday presented detailed clinical trial data on the first Alzheimer’s treatment shown to clearly, albeit modestly, slow the disease’s normal cognitive decline. The antibody therapy has buoyed a field marked by decades of failures. Now, it appears to be on the cusp of being greenlit by the U.S. Food and Drug Administration (FDA). Yet other researchers warn of potential risks, including brain swelling and brain hemorrhages that were linked to the recently disclosed deaths of two trial participants wh...
Source: Science of Aging Knowledge Environment - December 1, 2022 Category: Geriatrics Source Type: research

FDA Approves Expanded Peripheral Artery Disease (PAD) Indication for XARELTO ® (rivaroxaban) Plus Aspirin to Include Patients After Lower-Extremity Revascularization (LER) Due to Symptomatic PAD
RARITAN, N.J., August 24, 2021 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that the U.S. Food and Drug Administration (FDA) has approved an expanded peripheral artery disease (PAD) indication for the XARELTO® (rivaroxaban) vascular dose (2.5 mg twice daily plus aspirin 100 mg once daily) to include patients following recent lower-extremity revascularization (LER) due to symptomatic PAD. The approval is based on data from the Phase 3 VOYAGER PAD study. With this approval, XARELTO® is the first and only therapy indicated to help reduce the risks of major cardiovascular (CV) events in p...
Source: Johnson and Johnson - August 24, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news

Janssen Submits Application to U.S. FDA for New Indication to Expand Use of XARELTO ® (rivaroxaban) in Patients with Peripheral Artery Disease
RARITAN, NJ, October 26, 2020 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today it has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for a new indication to expand the use of XARELTO® (rivaroxaban) in patients with peripheral artery disease (PAD). If approved, this new indication for the XARELTO® vascular dose (2.5 mg twice daily plus aspirin 75-100 mg once daily) would include reducing the risk of major thrombotic vascular events such as heart attack, stroke and amputation in patients after recent lower-extremity revascularization, a c...
Source: Johnson and Johnson - October 26, 2020 Category: Pharmaceuticals Tags: Innovation Source Type: news