Sanofi: CHMP greenlights Dupixent
(CercleFinance.com) - The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has delivered a favorable opinion on Dupixent's third indication (dupilumab).
The CHMP has recommended Dupixent's approval, in addition to intranasal corticosteroids for the treatment of severe sinonasal polyposis (SNP) in adults for whom therapy with systemic corticosteroids and/or surgery do not provide adequate disease control.
Dupixent will be the first biologic medecine available for this category of patients in the European Union. The European Commission (EC) is expected to make a final decision on Dupixent's request for approval in the next few months.
"The positive CHMP opinion is based on two pivotal Phase 3 trials (the 24-week SINUS-24 and 52-week SINUS-52) that evaluated Dupixent 300 mg every two weeks plus standard-of-care intranasal corticosteroids compared to placebo plus intranasal corticosteroids," Sanofi said.
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The CHMP has recommended Dupixent's approval, in addition to intranasal corticosteroids for the treatment of severe sinonasal polyposis (SNP) in adults for whom therapy with systemic corticosteroids and/or surgery do not provide adequate disease control.
Dupixent will be the first biologic medecine available for this category of patients in the European Union. The European Commission (EC) is expected to make a final decision on Dupixent's request for approval in the next few months.
"The positive CHMP opinion is based on two pivotal Phase 3 trials (the 24-week SINUS-24 and 52-week SINUS-52) that evaluated Dupixent 300 mg every two weeks plus standard-of-care intranasal corticosteroids compared to placebo plus intranasal corticosteroids," Sanofi said.
Copyright (c) 2019 CercleFinance.com. All rights reserved.