Overseas Regulator Helps Ipsen Score A First In Australia
Ipsen’s tyrosine kinase inhibitor, Cabometyx, is the first product to be registered under a new Australian procedure that aims to get prescription drugs to market faster by using medicine assessments already conducted by comparable overseas regulators.
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Ipsen CSO says CHMP recommendation for TKI Cabometyx should give it first mover advantage globally in liver cancer.
Prescription medicines could be approved faster in Australia after the Therapeutic Goods Administration issued an initial list of overseas agencies whose assessments reports it is prepared to rely on.
A parallel assessment mechanism that will allow new medicines in any therapeutic area to be considered for funding sooner is being introduced in New Zealand, where the new coalition government is working to repeal last year’s landmark Therapeutic Products Act.