ELI Lilly has confirmed today that a regulatory submission to the TGA is imminent and plans for a PBS listing application are under way for its novel biologic medicine donanemab, indicated for the treatment of early-stage Alzheimer's disease.
The company will work with the medicines regulator, Federal Government and its reimbursement advisors to "ensure that Australians with early Alzheimer's disease receive access to donanemab at the earliest opportunity," shared Tori Brown, General Manager, Eli Lilly Australia & New Zealand.
The announcement comes as a landmark international research paper has just been published, HERE, looking into the efficacy and safety of donanemab as demonstrated in a Phase III trial with 1,736 participants, with early symptomatic Alzheimer's disease and amyloid and tau pathology.
Participants showed 35% slowing of clinical (cognitive and functional) decline over 18 months, while across the whole study group there was a 22% slowdown in disease progression.
Dementia Australia CEO Maree McCabe said donanemab has been shown to slow the progression of symptoms of early Alzheimer's disease.
"These results provide much needed hope for people who are developing symptoms, have mild cognitive impairment or who are in the early stages of Alzheimer's disease," McCabe said.
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