Sobi Receives Positive CHMP Opinion Recommending Approval Of Efanesoctocog Alfa For Once-Weekly Treatment Of Haemophilia A
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Sobi announced that the CHMP of the European Medicines Agency has recommended approval of efanesoctocog alfa for haemophilia A treatment. This once-weekly therapy has shown significant improvements in bleed protection and quality of life in clinical studies. Efanesoctocog alfa was approved in the US by the FDA in February 2023, having received Breakthrough Therapy, Fast Track, and Orphan Drug designations.
April 26, 2024 | 12:07 pm
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Sobi's efanesoctocog alfa, recommended for approval by the CHMP for haemophilia A treatment, could significantly impact Sanofi's (SNY) market presence in the EU, following its US FDA approval.
The positive CHMP opinion for efanesoctocog alfa represents a significant regulatory milestone that could enhance Sanofi's (SNY) competitive position in the haemophilia treatment market in the EU. Given the therapy's potential to improve treatment outcomes and quality of life for patients, it is likely to see strong market adoption. This, combined with its prior approval in the US, positions Sanofi for potential revenue growth in both markets.
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