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Roche Hemophilia Drug Gets Breakthrough Therapy Designation
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Roche Holding AG’s (RHHBY - Free Report) member Genentech announced that the FDA has granted Breakthrough Therapy Designation to its hemophilia drug, Hemlibra (emicizumab-kxwh). The designation was granted to Hemlibra for treatment of people with hemophilia A without factor VIII inhibitors.
The designation aims to expedite the development and review of drugs intended to treat serious or life-threatening conditions and provide patients access to these as soon as possible.
This designation is based on data from the phase III HAVEN 3 study in people 12 years or older with hemophilia A without inhibitors. In the study, Hemlibra prophylaxis dosed subcutaneously every week or every two weeks showed a statistically significant and clinically meaningful reduction in treated bleeds compared to no prophylaxis. The study met its primary endpoint as well as key secondary endpoints with Hemlibra significantly reducing bleeding.
Roche’s stock has lost 11.6% over a year compared with industry's gain of 8.9%.
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 in September 2015.
In January 2018, the EU Committee for Medicinal Products for Human Use (“CHMP”) 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 potential approval will further boost Roche’s hematology portfolio which includes approved drugs like MabThera/Rituxan, Gazyva/Gazyvaro, Tecentriq and Venclexta
We note that Roche is developing Venclexta in collaboration with AbbVie (ABBV - Free Report) . Both companies are jointly commercializing the drug in the United States. AbbVie is commercializing the drug outside the United States.
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 (NVS - Free Report) has already launched its biosimilar version of Rituxan/ MabThera in Europe. Amgen (AMGN - Free Report) 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.
Earlier this year, credit bureau Equifax announced a massive data breach affecting 2 out of every 3 Americans. The cybersecurity industry is expanding quickly in response to this and similar events. But some stocks are better investments than others.
Zacks has just released Cybersecurity! An Investor’s Guide to help Zacks.com readers make the most of the $170 billion per year investment opportunity created by hackers and other threats. It reveals 4 stocks worth looking into right away.
Image: Bigstock
Roche Hemophilia Drug Gets Breakthrough Therapy Designation
Roche Holding AG’s (RHHBY - Free Report) member Genentech announced that the FDA has granted Breakthrough Therapy Designation to its hemophilia drug, Hemlibra (emicizumab-kxwh). The designation was granted to Hemlibra for treatment of people with hemophilia A without factor VIII inhibitors.
The designation aims to expedite the development and review of drugs intended to treat serious or life-threatening conditions and provide patients access to these as soon as possible.
This designation is based on data from the phase III HAVEN 3 study in people 12 years or older with hemophilia A without inhibitors. In the study, Hemlibra prophylaxis dosed subcutaneously every week or every two weeks showed a statistically significant and clinically meaningful reduction in treated bleeds compared to no prophylaxis. The study met its primary endpoint as well as key secondary endpoints with Hemlibra significantly reducing bleeding.
Roche’s stock has lost 11.6% over a year compared with industry's gain of 8.9%.
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 in September 2015.
In January 2018, the EU Committee for Medicinal Products for Human Use (“CHMP”) 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 potential approval will further boost Roche’s hematology portfolio which includes approved drugs like MabThera/Rituxan, Gazyva/Gazyvaro, Tecentriq and Venclexta
We note that Roche is developing Venclexta in collaboration with AbbVie (ABBV - Free Report) . Both companies are jointly commercializing the drug in the United States. AbbVie is commercializing the drug outside the United States.
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 (NVS - Free Report) has already launched its biosimilar version of Rituxan/ MabThera in Europe. Amgen (AMGN - Free Report) 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.
Roche Holding AG Price
Roche Holding AG Price | Roche Holding AG Quote
Zacks Rank
Roche currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Can Hackers Put Money INTO Your Portfolio?
Earlier this year, credit bureau Equifax announced a massive data breach affecting 2 out of every 3 Americans. The cybersecurity industry is expanding quickly in response to this and similar events. But some stocks are better investments than others.
Zacks has just released Cybersecurity! An Investor’s Guide to help Zacks.com readers make the most of the $170 billion per year investment opportunity created by hackers and other threats. It reveals 4 stocks worth looking into right away.
Download the new report now>>