In October 2024, the TGA made the decision not to register lecanemab (LEQEMBI) on the Australian Register of Therapeutic Goods (ARTG) for the treatment of patients with Mild Cognitive Impairment (MCI) due to Alzheimer's disease and Mild Alzheimer's dementia (early Alzheimer's disease).
In December 2024, Eisai Australia Pty Ltd, requested reconsideration of the decision not to register the medicine lecanemab (LEQEMBI) on the ARTG under section 60 of the Therapeutic Goods Act 1989 (the Act).
The TGA delegate has confirmed the initial decision to not register the medicine on the basis that the safety and efficacy of the medicine, for the purposes which it was proposed to be used (therapeutic indication), were not satisfactorily established by the available evidence.
What were the main reasons for the decision to refuse registration?
The provided clinical study data demonstrated that patients treated with LEQEMBI showed some slowing in disease progression in some populations compared to those given a placebo, but this was not demonstrated in all populations covered by the therapeutic indications proposed by Eisai Australia Pty Ltd.
During the 60-day timeframe of the reconsideration process, a number of additional proposals were put forward by the applicant.
The Delegate found that both safety and efficacy are satisfactorily established for APOE4 noncarriers. In the course of the reconsideration of the initial decision, the Delegate proposed an alternative indication limited to APOE4 noncarriers, however, the Applicant indicated it is not willing to agree to seek an indication restricted to this population. The Applicant proposed that APOE4-heterozygotes should be treated in specialist centres and supervised by physicians with expertise in monitoring for ARIA. However after consideration, the Delegate was not satisfied that this wording would be specific enough to support clinicians and address the outstanding safety concerns for patients who are APOE4 heterozygous carriers.
