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 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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