Latest From Incyte Corp.
Roche has secured accelerated assessment at the European Medicines Agency for its new immunosuppressant, satralizumab. The outcomes of five other fast-track requests that companies have made for their planned marketing authorization applications are still unknown.
Results from two studies at ESMO point to a targeted future for cholangiocarinoma with Agios and Incyte both planning year-end FDA filings in different patient subsets.
The outcomes of six requests for accelerated assessment that companies have made for their planned marketing authorization applications in the EU are still unknown.
A second Phase III JADE study showed statistically significant skin clearance and reduced pruritus in atopic dermatitis, although safety is harder to evaluate for now. A filing planned for 2020 will include results from a cross-study comparison evaluating abrocitinib versus Dupixent.
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