UCB: FDA and EMA to review bimekizumab
(CercleFinance.com) - UCB announced on Tuesday that the US and European health authorities have agreed to review the marketing package for bimekizumab, its experimental treatment of psoriasis.
In the United States, the FDA has accepted an application for a biologic product licence for bimekizumab in the treatment of moderate-to-severe plaque psoriasis, UCB says.
The European Medicines Agency (EMA) has accepted the examination of the application for marketing authorisation of the medicinal product in the same indication, it adds.
The Belgian pharmaceutical group says that both files are supported by phase III data that demonstrated the superiority of bimekizumab over placebo, Janssen's Stelara and AbbVie's Humira.
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In the United States, the FDA has accepted an application for a biologic product licence for bimekizumab in the treatment of moderate-to-severe plaque psoriasis, UCB says.
The European Medicines Agency (EMA) has accepted the examination of the application for marketing authorisation of the medicinal product in the same indication, it adds.
The Belgian pharmaceutical group says that both files are supported by phase III data that demonstrated the superiority of bimekizumab over placebo, Janssen's Stelara and AbbVie's Humira.
Copyright (c) 2020 CercleFinance.com. All rights reserved.