Australia’s regulatory agency rejected Biogen and Eisai’s Alzheimer’s drug Leqembi, noting that the drug’s efficacy doesn’t outweigh the safety risks.
Australia’s Therapeutic Goods Administration (TGA) said Wednesday that while patients on the drug saw “a reduction in disease progression” compared to placebo, it wasn’t “significant enough to provide a meaningful clinical benefit or to outweigh the associated safety risks.” The TGA noted that it also took into account the frequency of amyloid-related imaging abnormalities (ARIA), a side effect of Leqembi that can cause brain swelling and bleeding.
In response, Eisai said it plans to ask the TGA to reconsider the decision within 90 days. Following that request, the regulator will make a final decision within two months.
Although Leqembi is already approved in the US, parts of Asia, Israel and the UAE, Australia has followed in the footsteps of other regulators that have been hesitant to approve or cover the treatment.
It was authorized in August by the UK’s Medicines and Healthcare products Regulatory Agency, though the decision doesn’t guarantee coverage of Leqembi by the NHS, the UK’s publicly funded healthcare system. Whether the drug will be covered is up to the National Institute for Health and Care Excellence, which published draft guidance in August that said the drug’s benefits don’t outweigh its costs.
The European Medicines Agency in July rejected the treatment, also citing the potential for serious side effects.
In March of last year, Eisai execs projected $7 billion in worldwide Leqembi sales by 2030, and TD Cowen analysts said this summer that the EMA’s decision didn’t impact its sales estimate of $3.6 billion by 2028.
The drug brought in revenue of JPY 6.3 billion (about $42 million) in its first fiscal quarter of 2024, which went through the end of June. That’s up from the JPY 2.83 billion (about $18.9 million) in revenue it reported in the previous quarter.