A panel of consultants specializesof the is debating whether they should recommendfrom thefrog approval traditional regulatory of the It isof the Uniof the for the new medicine against Alzheimer’s, from the behold It is from the biogenainfrom the this Friday (9).
Leqembi got approval speeds upfrom the for the Agency of food and medicines (FFROM THEin the acronym in English) of the USA in January, based on your abilityfrom theto remove toxic amyloid plaques from the brain. A agency You must make your decision about the approval traditional until July 6th.
The reviewers from the team from the agency health said on Wednesday that the late-stage test from the beholdshowing that Leqembi delayed cognitive decline by 27% in patients with Alzheimer’s initial, seems to confirm the benefit of the medicine. The test did not raise any new security issues.
Dr. Teresa Buracchio, interim director of the neuroscience office from the FFROM THEsaid that the agency is aware of the public debate about whether the resultsof the of the study were clinically significant.
She told the panel that the agency believe that the from theof the end-stage drugs make “a compelling case” that the drug offers a clinically significant benefit, that FFROM THE defines it as an improvement in how the patient feels, functions or survives.
However, she pointed out that the agency ainfrom the not decided on the approval of the treatment and your vision may changefrom ther based on panel discussions.
A approval regular would make the Leqembi the first in its class of medicines that work by removing sticky amyloid plaques from the brain to reach the regulatory milestone.
Analysts predict that salesfrom thes from the Leqembi will reach US$1 billion by 2026 and US$5.7 billion by 2030.
A agency also asked experts to discuss the risks and benefits of the treatment, focusing on people who carry two copies of the risk gene for Alzheimer’s called APOE4, which can increase side effects such as brain swelling.
AFFROM THE also want information about the use from the drug in patients taking blood thinners and in those with a condition calledfrom the cerebral amyloid angiopathy, in which the amyloid protein – which is targeted by Leqembi – builds up in the walls from thes arteries and can cause bleeding in the brain.
(Reporting by Leroy Leo, Khushi Mandowara and Julie Steenhuysen)
Source: CNN Brasil
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