Dual Approval For Verzenio Under International Review Scheme

The joint review by Australia and Canada of the metastatic breast cancer drug, Verzenio, helped regulators in both jurisdictions achieve efficiencies.

Handshake
Australian and Canadian regulators highlight the advantages of working together • Source: Shutterstock

Eli Lilly’s metastatic breast cancer drug, Verzenio (abemaciclib), has been approved in Australia and Canada, making it the second medicine to be reviewed under an international work-sharing program for new chemical entities (NCEs) that was set up last year.

Australia's Therapeutic Goods Administration and Health Canada carried out a joint review of Verzenio under the Australia-Canada-Singapore-Switzerland (ACSS) Consortium. The...

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