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.

Earth — Australia is using reports from comparable overseas regulators to support drug registrations • Source: Shutterstock

Ipsen has become the first company to get a product registered under a new pathway in Australia that allows the Therapeutic Goods Administration to speed up prescription drug approvals by making use of medicine assessments conducted by a comparable overseas regulator, or COR.

A new indication for the company’s renal cancer drug, Cabometyx (cabozantinib), was placed on the Australian Register of Therapeutic Goods...