Phase III Updates Bode Well For Filings Of Roche's Emicizumab In Hemophilia
Roche believes it can address thrombotic safety issues that cropped up with bispecific antibody emicizumab by providing regulators with guidance on dosing.
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Genentech/Roche's Hemlibra, now FDA-approved for hemophilia A patients with inhibitors, offers a once-weekly injection, impressive efficacy with a safety concern that appears to be manageable, and a price that's at least half the cost of the established prophylaxis regimen.
The last three months of the year should see data reporting from a number of key studies for novel products including Roche's emicizumab. Scrip takes a look at some of the more interesting studies expected by year end, with the help of analysts from Informa's Biomedtracker.
Analysts had already been doubtful about the prospects for success in the Spectri study. A second Phase III trial is ongoing, but the candidate is already being removed from revenue models.