Roche RHHBY announced that the EU Committee for Medicinal Products for Human Use (“CHMP”) has adopted a positive opinion for Hemlibra (emicizumab) for routine prophylaxis of bleeding episodes in patients suffering from hemophilia A with factor VIII inhibitors.
The CHMP has recommended the drug for use in all age groups.
The Marketing Authorisation Application is being reviewed under accelerated assessment.
A final decision is expected from the European Commission shortly. The CHMP recommendation is based on the positive results of two pivotal clinical studies for people with haemophilia A with inhibitors, the phase III HAVEN 1 and HAVEN 2 studies.
We note that the FDA approved Hemlibra for routine prophylaxis to event or reduce the frequency of bleeding episodes in adults and children with haemophilia A with factor VIII inhibitors in November 2017. Hemlibra was reviewed by the FDA under Priority Review and granted Breakthrough Therapy Designation by the FDA in people aged 12 years or older with haemophilia A with inhibitors in September 2015.
Meanwhile, Hemlibra is being evaluated in a clinical development program that includes two additional phase III studies, HAVEN 3 and HAVEN 4. Results from HAVEN 3 showed a statistically significant and clinically meaningful reduction in the number of treated bleeds over time in adults and adolescents (12 years of age or older) with haemophilia A without inhibitors who received Hemlibra prophylaxis every week or every two weeks, compared with those receiving no prophylaxis. Interim results from HAVEN 4 showed a clinically meaningful control of bleeding in adults and adolescents (12 years of age or older) with haemophilia A with or without inhibitors who received Hemlibra prophylaxis once every four weeks.
A potential approval in Europe will further boost Roche’s hematology portfolio which includes approved drugs like MabThera/Rituxan, Gazyva/Gazyvaro, Tecentriq and Venclexta as well as an encouraging pipeline comprising candidates like polatuzumab vedotin/RG7596 and a small-molecule antagonist of MDM2 (idasanutlin/RG7388).
We note that Roche is developing Venclexta in collaboration with AbbVie ABBV. Both companies are jointly commercializing in the United States. AbbVie is commercializing the drug outside the United States.
Earlier in the month, the European Commission granted marketing authorization for multiple sclerosis (MS) drug Ocrevus.
The drug is approved for active relapsing forms of MS defined by clinical or imaging features as well as for early primary progressive MS in terms of disease duration and level of disability, and with imaging features characteristic of inflammatory activity.
Roche’s stock has lost 3.1% over a year compared with industry's gain of 2.9%.
Approval of new drugs and a potential label expansion of existing drugs bode well for Roche as its legacy drugs like Herceptin, MabThera are facing competition from biosimilars.
Novartis AG NVS has already launched its biosimilar version of Rituxan/ MabThera in Europe. Amgen AMGN has also obtained FDA approval for a biosimilar version of Avastin for treatment of five types of cancers including lung cancer, colorectal cancer, glioblastoma, renal cell carcinoma and cervix cancer.
Zacks Rank
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