Biogen and its partner Eisai recently jointly announced that the US Food and Drug Administration (FDA) has approved the label update of aduhelm (aduanumab avwa) 100mg / ml injection. This update includes the addition of some contents to the part of indications and usage (Section 1) to emphasize the disease stage studied in clinical trials (italics, bold and yellow parts are the updated contents)
Aduhelm is suitable for the treatment of Alzheimer's disease (AD). Aduhelm should start treatment for AD patients with mild cognitive impairment or mild dementia in the early stage of the disease, which is the population treated in clinical trials. There is no data on the safety or efficacy of aduhelm in the earlier or later stages of the disease under study. This indication is based on observations in patients treated with aduhelm β The reduction of amyloid plaques was approved through the accelerated approval process. Further approval for this indication may depend on the validation of clinical benefits in confirmatory clinical trials.
Alfred sandrock, R & D director of Bojian, said: "based on our ongoing dialogue with prescribing doctors, FDA and patient rights advocates, we have submitted this label update to further clarify the patient population studied in the three aduhelm clinical trials supporting approval. As clinical practice adapts to this important initiative, we are committed to continuing to listen to the needs of the community. "
This update clarifies indications by highlighting information on disease stages studied in aduhelm clinical trials. Bojian and Weicai have previously exchanged information on the study population, including in the company statement issued on June 23, 2021.
Ad is an irreversible and progressive brain disease, which will slowly destroy people's memory and thinking ability, and ultimately destroy the ability to perform simple tasks. Although the specific cause of ad is not fully clear, its characteristics are brain changes, including amyloid plaques and tangled neurofibrils (tau), which leads to the loss of neurons and their connections. These changes affect a person's ability to remember and think.
In June of this year, aduhelm was approved by FDA to treat ad. Aduhelm represents the first drug approved for the treatment of AD, the first new treatment approved for ad since 2003, and the first one for basic pathophysiology of AD.
In three separate clinical studies (Study 1: nct02484547; Study 2: nct02484547; Study 2: nct02484547); Study 2: nct02477800; Study 3: nct01677572). These included a double-blind, randomized, placebo-controlled dose range study in patients with AD. Patients treated with aduhelm, amyloid β Plaque was significantly reduced in a dose and time-dependent manner, compared with the control group β Amyloid plaques did not decrease.
These results support aduhelm's accelerated approval, which is based on amyloid in the brain β A surrogate endpoint for plaque reduction is a hallmark of AD. In this study, positron emission tomography (PET) imaging was used to detect amyloid β Plaques were quantified to estimate amyloid in the complex of brain regions expected to be widely affected by AD pathology β Plaque levels were compared with areas of the brain that were not expected to be affected by this pathology.
