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Sanofi's Blood Clotting Drug Gets Positive CHMP Opinion
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Sanofi (SNY - Free Report) announced that the Committee for Medicinal Products for Human Use (“CHMP”) of the European Medicines Agency (“EMA”) has issued a positive opinion recommending approval of Cablivi (caplacizumab). A marketing authorization application (“MAA”) is seeking approval of the candidate for the treatment of patients experiencing an episode of acquired thrombotic thrombocytopenic purpura (aTTP), a rare blood-clotting disorder.
This is the first drug to receive CHMP recommendation for the treatment of aTTP. A potential approval by the European Medical Agency, expected in the coming months, will help the drug gain market share with first-mover advantage in this indication.
Sanofi added the candidate to its pipeline with the acquisition of Ablynx earlier in January.
The stock has lost 7% so far this year, underperforming the industry’s decrease of 5.1%.
The MAA was backed by positive data from phase II TITAN study and phase III HERCULES study evaluating Cablivi in combination with standard-of-care. Data showed that the combination achieved a significantly shorter time to platelet count response and significant reductions in aTTP-related death, recurrence of aTTP, or at least one major thromboembolic event.
A follow-up study is evaluating Cablivi in patients who have completed the HERCULES study for long-term safety and efficacy of the candidate.
A biologics license application is expected to be filed for Cablivi in the United States this year.
We note that Genentech, a subsidiary of Roche (RHHBY - Free Report) and Biogen, Inc. (BIIB - Free Report) are developing Rituxan in partnership which is currently being evaluated in a phase II study for the treatment of aTTP.
Sanofi is focused on strengthening its leadership in rare diseases and has made a few acquisitions this year so far in this regard. Albynx acquisition has also added an anti-Respiratory Syncytial Virus nanobody to Sanofi’s pipeline. Apart from Albynx, Sanofi acquired Bioverativ, adding a hemophilia candidate. The company also obtained global rights for fitusiran from Alnylam Pharmaceuticals, Inc. (ALNY - Free Report) , which is being developed for the treatment of hemophilia A and B.
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Sanofi's Blood Clotting Drug Gets Positive CHMP Opinion
Sanofi (SNY - Free Report) announced that the Committee for Medicinal Products for Human Use (“CHMP”) of the European Medicines Agency (“EMA”) has issued a positive opinion recommending approval of Cablivi (caplacizumab). A marketing authorization application (“MAA”) is seeking approval of the candidate for the treatment of patients experiencing an episode of acquired thrombotic thrombocytopenic purpura (aTTP), a rare blood-clotting disorder.
This is the first drug to receive CHMP recommendation for the treatment of aTTP. A potential approval by the European Medical Agency, expected in the coming months, will help the drug gain market share with first-mover advantage in this indication.
Sanofi added the candidate to its pipeline with the acquisition of Ablynx earlier in January.
The stock has lost 7% so far this year, underperforming the industry’s decrease of 5.1%.
The MAA was backed by positive data from phase II TITAN study and phase III HERCULES study evaluating Cablivi in combination with standard-of-care. Data showed that the combination achieved a significantly shorter time to platelet count response and significant reductions in aTTP-related death, recurrence of aTTP, or at least one major thromboembolic event.
A follow-up study is evaluating Cablivi in patients who have completed the HERCULES study for long-term safety and efficacy of the candidate.
A biologics license application is expected to be filed for Cablivi in the United States this year.
We note that Genentech, a subsidiary of Roche (RHHBY - Free Report) and Biogen, Inc. (BIIB - Free Report) are developing Rituxan in partnership which is currently being evaluated in a phase II study for the treatment of aTTP.
Sanofi is focused on strengthening its leadership in rare diseases and has made a few acquisitions this year so far in this regard. Albynx acquisition has also added an anti-Respiratory Syncytial Virus nanobody to Sanofi’s pipeline. Apart from Albynx, Sanofi acquired Bioverativ, adding a hemophilia candidate. The company also obtained global rights for fitusiran from Alnylam Pharmaceuticals, Inc. (ALNY - Free Report) , which is being developed for the treatment of hemophilia A and B.
Sanofi Price
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Sanofi currently carries a Zacks Rank #4 (Sell).
You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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It's hard to believe, even for us at Zacks. But while the market gained +21.9% in 2017, our top stock-picking screens have returned +115.0%, +109.3%, +104.9%, +98.6%, and +67.1%.
And this outperformance has not just been a recent phenomenon. Over the years it has been remarkably consistent. From 2000 - 2017, the composite yearly average gain for these strategies has beaten the market more than 19X over. Maybe even more remarkable is the fact that we're willing to share their latest stocks with you without cost or obligation.
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