EU Filings For Amgen/UCB’s Evenity, iv Relenza From GSK, And A New PRIME Product
Products submitted for approval in the EU in recent weeks include Amgen/UCB’s potential new treatment for osteoporosis, romosozumab, an iv formulation of GSK’s flu treatment, zanamivir, and avacopan, a new immunosuppressant from ChemoCentryx that is getting support through the EMA’s PRIME scheme.
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Mitsubishi and Emmaus Life Sciences are among the companies that will find out this week whether the European Medicines Agency's drug evaluation committee, the CHMP, will recommend their new products for EU approval.
As Amgen’s main hope for extending its bone health franchise, romosozumab faces a second review at the FDA with a fuller dataset and an external analysis of cardiovascular risk.
J&J is hoping EU regulators will follow the US in fast-tracking the company’s prostate cancer franchise-extending drug apalutamide.