PARIS (Agefi-Dow Jones)–The pharmaceutical company Sanofi announced on Saturday that clinical trial results support the tolerance and safety profiles of its drug Dupixent for the treatment of patients suffering from chronic spontaneous urticaria (CSU) or eosinophilic esophagitis.
These “last minute” results were presented by Sanofi at the annual meeting of the American Academy of Allergy, Asthma and Immunology (AAAAI), which takes place until Monday in Phoenix, Arizona.
As part of this congress, detailed results from a phase 3 trial showed that the addition of Dupixent to antihistamines resulted in an almost two-fold reduction in itching and the activity of the urticaria, compared to the reference treatment only, with continuous improvements through week 24. “The safety results of this trial were similar to the known safety profile of Dupixent in its approved dermatological indications”, indicated Sanofi in a statement.
The potential use of Dupixent for the treatment of UCS is still in clinical development and no regulatory body has yet fully evaluated its safety and efficacy profiles in this indication.
The pharmaceutical company also presented at the AAAAI detailed positive results from a second phase 3 trial showing that treatment with Dupixent significantly improved the signs and symptoms of eosinophilic esophagitis at 24 weeks, compared to placebo, in patients 12 years of age and older. “The safety results of the trial are consistent with the known safety profile of Dupixent in its approved indications,” said Sanofi, which expects regulatory submissions for Dupixent in this indication in the United States and elsewhere in the world in 2022. .
In September 2020, the Food and Drug Administration (FDA), the US health authority, granted Breakthrough Therapy Designation to Dupixent for the treatment of eosinophilic esophagitis in patients 12 years of age and older. . In 2017, Dupixent was also granted “orphan drug” status by the FDA for the potential treatment of eosinophilic esophagitis.
The potential use of Dupixent for the treatment of eosinophilic esophagitis is still in clinical development, as no regulatory body has yet evaluated its safety and efficacy profiles in this indication.
Dupixent, the trade name for dupilumab, is being jointly developed by Sanofi and Regeneron under a global collaboration agreement.
-Dimitri Delmond, Agefi-Dow Jones; +33 (0)1 41 27 47 31; [email protected] ed: JXM
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February 28, 2022 01:50 ET (06:50 GMT)