Roche HoldingsRHHBY announced that the FDA has approved Hemlibra (emicizumab-kxwh) for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and children with haemophilia A with factor VIII inhibitors.
The approval comes three months ahead of the assigned PDUFA date of Feb 23, 2018. The drug was reviewed by the FDA under Priority Review.
Meanwhile, data from HAVEN 1 and HAVEN 2 are being reviewed under accelerated assessment by the European Medicines Agency (EMA).
Roche's legacy drugs like Herceptin, MabThera are already facing competition from biosimilars. Though the approval of new drugs certainly boosts Roche's portfolio, it must be noted that Hemlibra carries a boxed warning of thrombotic microangiopathy (TMA) and blood clots which will limit sales potential.
Moreover, competition is intense in the haemophilia market too. Shire plc's SHPG hemophila drugs like Advate (hemophilia A) and Rixubis (hemophilia B) pose stiff competition to Roche. Also, the presence of Novo Nordisk NVO in the same space is a concern.
Meanwhile, Hemlibra is currently being evaluated in a clinical development program that includes two additional phase III studies. HAVEN 3 is evaluating Hemlibra prophylaxis dosed once weekly or once every other week in people 12 years of age or older with haemophilia A without inhibitors to factor VIII. HAVEN 4 is evaluating Hemlibra prophylaxis dosed every four weeks in people 12 years of age or older with haemophilia A with or without inhibitors.
Roche's stock has gained only 4% year to date compared with industry 's growth of 18%.
Roche also obtained FDA approval for Gazyva in combination with chemotherapy, followed by Gazyva alone in those who responded, for previously untreated advanced follicular lymphoma (stage II bulky, III or IV).
The drug is already approved in combination with chlorambucil to treat chronic lymphocytic leukemia (CLL) in adults who have not had previous CLL treatment.
Roche's hematology portfolio consists of approved drugs like MabThera/Rituxan (rituximab), Gazyva/Gazyvara, and Venclexta/Venclyxto (venetoclax) in collaboration with AbbVie, Inc . ABBV .
Roche carries a Zacks Rank #3 (Hold). You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here.
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