Roche's Hemlibra Gets Positive CHMP Opinion For Label Expansion

(RTTNews) - Roche Holding AG (RHHBY) announced that the European Medicines Agency's Committee for Medicinal Products for Human Use, or CHMP, has recommended the label expansion of Hemlibra to include people with moderate haemophilia A without factor VIII inhibitors.

The positive CHMP opinion is based on the results of the phase III HAVEN 6 study, in which Hemlibra demonstrated effective bleed control and a favorable safety profile in people with non-severe Hemophilia A without factor VIII inhibitors, where prophylaxis was clinically indicated.

According to the company, Hemophilia A affects around 900,000 people worldwide, approximately 14% of whom have a moderate form of the disorder. . Hemlibra is already approved for severe haemophilia A in the European Union.

The European Commission's final decision on the expanded indication of Hemlibra is expected to be announced in the coming months.

If approved for the expanded indication, Hemlibra will provide an effective and convenient prophylactic treatment option with a favorable safety profile, for people in the EU with moderate haemophilia A with a severe bleeding phenotype.

RHHBY has traded in a range of $37.88 to $53.86 in the last 52 weeks. The stock closed Thursdays's trading at $40.56, down 1.6%.