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news.Belgian drugmaker UCB has received FDA approval for Cimzia, a PEGylated anti-TNF (Tumor Necrosis Factor), for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA).
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Cimzia can be dosed at 400 mg initially and at weeks two and four, followed by 200 mg every other week; for maintenance dosing, 400 mg every four weeks can be considered the company said.
FDA approved Cimzia based on data from from four multi-center placebo-controlled phase III trials involving more than 2300 patients with RA that showed Cimzia significantly reduced arthritis symptoms.
Roch Doliveux, Chief Executive Officer of UCB, said: The approval of Cimzia for moderate to severe rheumatoid arthritis in the US is a major milestone for UCB, and most importantly, for people seeking a new treatment option to manage this debilitating condition.
I am also proud of our partnership with OXO and of the fact that RA patients were directly involved in the design and development of our new prefilled syringe, which is designed to make self-administration easy for people living with rheumatoid arthritis, he added.