Biogen (BIIB) said Monday the Therapeutic Goods Administration of Australia has reaffirmed its earlier decision to reject lecanemab as a treatment for early Alzheimer's disease.
The TGA suggested restricting the drug's use to ApoE4 noncarriers due to safety risks, but Biogen's revised proposals were declined as well, the company said.
Biogen said the ruling excludes nearly 70% of potential patients and differs from approvals granted in 11 other countries, including the US and Japan.
The company said it is evaluating its next steps, including a possible appeal to the administrative review tribunal, to make the treatment available in Australia.
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