Breakthrough Alzheimer's Drug Donanemab Approved in Australia

Australia's TGA has approved donanemab for early-stage Alzheimer's patients, following its approval in several countries. The drug, targeting amyloid proteins, shows promise in slowing disease progression but comes with significant costs and risks. Cost and access limitations may affect its availability to patients in need.

In a significant development, Australia's Therapeutic Goods Administration (TGA) has approved the drug donanemab for individuals in the early phases of Alzheimer's disease. Previously sanctioned in countries including the United States, donanemab is gaining traction as a promising treatment option in the fight against dementia.

Designed as a monoclonal antibody, donanemab targets amyloid protein deposits in the brain, which are believed to be a primary driver of Alzheimer's. Recent clinical trials highlight that patients with early signs of Alzheimer's or mild cognitive impairment experienced a 35% slower progression when treated with donanemab. However, the drug's use is not without risk, as some participants experienced brain swelling and other side effects.

Despite its potential, donanemab's high cost, estimated between AUD 40,000 and AUD 80,000 annually, may restrict access for many. Eli Lilly, its manufacturer, is seeking inclusion on Australia's Pharmaceutical Benefits Scheme to make the drug more accessible. Concerns around safety and economic impact continue to be central to discussions about this new treatment.

(With inputs from agencies.)