SanofiSNY announced that the European Commission has approved a rare blood disorder drug, Cablivi (caplacizumab) for the treatment of acquired thrombotic thrombocytopenic purpura (aTTP).
This is the first drug to receive approval for this indication. This may help the drug to gain leading market share with first-mover advantage in this indication.
The decision was expected as the Committee for Medicinal Products for Human Use ("CHMP") had recommended the drug's approval in July.
The FDA has also accepted the Biologics License Application for caplacizumab under priority review for a similar indication. A decision is expected on Feb 6, 2019.
Sanofi had added caplacizumab to its pipeline with the acquisition of Belgium-based Ablynx earlier this year for €3.9 billion after bidding out Novo Nordisk NVO .
The company's stock has lost 0.4% so far this year against the industry 's decrease of 4.6%.
The approval was based on data from phase II TITAN study and phase III HERCULES study. The drug in combination with current standard-of-care significantly shortened time to platelet count response. It also significantly reduced in aTTP-related death, recurrence of aTTP, or at least one major thromboembolic event.
The blood disorder is a fatal disease, which causes death among 20% of patients treated with current standard-of-care within 30 days of diagnosis.
Sanofi is focused on strengthening its leadership in rare diseases, especially developing treatment for rare blood disorders that have significant unmet need. The company also acquired Bioverativ this year, which added a hemophilia candidate to its pipeline. It also acquired global rights for fitusiran from Alnylam Pharmaceuticals, Inc. ALNY , which is being developed for the treatment of hemophilia A and B.
Sanofi Price | Sanofi Quote
Zacks Rank & Stock to Consider
Sanofi currently has a Zacks Rank #4 (Sell).
Eli Lilly and Company LLY is a better-ranked stock from the same space, carrying a Zacks Rank #2 (Buy). You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here .
Lilly's earnings per share estimates have increased from $5.15 to $5.47 for 2018 and from $5.47 to $5.69 for 2019 over the past 60 days. The company delivered a positive earnings surprise in all the trailing four quarters with an average beat of 10.15%. The stock has increased 25.1% so far this year.
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