Important added FDA indication for hemophilia A drug Hemlibra

There was good news for Roche (ROG: SIX) with the coveted wider indication for its hemophilia drug in the USA, so increasing its focus on diseases beyond cancer to help replace revenue from older products that have, or will soon, lost patent exclusivity.

The Swiss pharma giant revealed yesterday that the US Food and Drug Administration has approved Hemlibra (emicizumab-kxwh) for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and children, ages newborn and older, with hemophilia A without factor VIII inhibitors.

In November 2017, the FDA approved Hemlibra for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and children with hemophilia A with factor VIII inhibitors. The European Commission did likewise in February this year.