Erlyand Gains First Registration Under TGA-Health Canada Pilot Program
Johonson & Johnson’s prostate cancer treatment Erlyand (apalutamide) became the first drug evaluated under the Australia-Canada-Singapore-Switzerland Consortium’s work sharing pilot to be registered on the Australian Register of Therapeutic Goods.
The chemical entity work-sharing pilot program developed by Health Canada and Australia’s Therapeutic Goods Administration is intended to reduce burdens on regulators and industry in the two countries. The program could eventually expand to include Singapore and Switzerland.
The drug will be marketed in Canada by Janssen under the name Erleada.