Roche gets priority review for Hemlibra's second indication; Orasis gets $13M B round for presbyopia eye drop
→ Roche $RHHBY is now one step closer to realizing its blockbuster ambitions for Hemlibra, securing a priority review for a second, hugely important indication — hemophilia A patients who haven’t developed resistance to factor replacement therapy, more commonly known as patients without factor VIII inhibitors or non-inhibitor patients. The announcement comes days after the pharma giant’s Genentech group rolled out a slate of new Phase III data that backed Hemlibra’s case for reducing treated bleeds: a 97% reduction compared with those with no prophylaxis and 68% compared to previous factor VIII treatment. Hemlibra was originally approved to treat patients with inhibitors. An approval here would make Roche an official rival of Shire, which has built a franchise around factor replacement therapy. The FDA — having already granted the drug breakthrough status — has promised to give a decision by October 4, 2018.
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