ADUHELM

批准信原文要点

This Prior Approval supplemental biologics license application provides to update the label with the latex statement for the prefilled syringe (PFS) and prefilled pen (PFP).

批准信原文要点

We also refer to our letter dated July 6, 2023, notifying you, under Section 505(o)(4) of the FDCA, of new safety information that we have determined should be included in the labeling for the class of monoclonal antibodies directed against aggregated forms of beta amyloid. This information pertains to the risk of increased risk of amyloid related imaging abnormalities (ARIA) in ApoE ε4 homozygotes treated with this class of drugs and to the risk of intracerebral hemorrhage greater than 1 cm.

批准信原文要点

This Prior Approval sBLA provides for the addition of clinical study data regarding plasma p-Tau 181 to the Clinical Pharmacology (12.2) and Clinical Studies (14) sections of the Prescribing Information (PI). This sBLA also includes revisions throughout the PI (Dosage and Administration [2.1-2.5], Warnings and Precautions [5.1], Adverse Reactions, and Patient Counseling Information [17]) that provide for updated information with respect to ARIA associated with the use of Aduhelm.

批准信原文要点

This Prior Approval sBLA provides for revisions to the Aduhelm labeling to add information regarding seizures in the Prescribing Information [Warnings and Precautions section (5.1) and Patient Counseling section (17)] and in the Medication Guide. This Prior Approval supplement also provides for more detailed guidance regarding detection of ARIA and dosing decisions in the setting of ARIA in the Prescribing Information [Dosage and Administration section (2.3) and Warnings and Precautions section (5.1)] and for language regarding the confirmation of amyloid beta pathology prior to initiating treatment [Dosage and Administration section (2.1)].

批准信原文要点

This Prior Approval supplemental biologics application provides an update to Section 1 (Indications and Usage) of the Prescribing Information, clarifying the population in which treatment should be initiated.