Cimzia approved for signs and symptoms of Crohn's disease - - Drug Topics

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Cimzia approved for signs and symptoms of Crohn's disease


Drug Topics




A new agent for reducing the signs and symptoms of Crohn's disease (CD) will soon be available. UCB Inc. has received word from the FDA that certolizumab pegol (Cimzia) has been approved in CD patients with moderate to severe active disease who have an inadequate response to conventional therapy. According to the company, the biologic targets tumor necrosis factor alpha (TNF-alpha), a cytokine that plays a key role in mediating pathological inflammation, and represents the first and only PEGylated anti-TNF-alpha on the market. The new treatment is dosed subcutaneously once every four weeks after the initial dosing of one injection every two weeks for the first three injections. Certolizumab utilizes Nektar Therapeutic's PEGylation platform. According to Nektar, pegylation increases a drug's circulation time in the bloodstream, leading to decreased immunogenicity and dosing frequency as well as increased bioavailability and improved drug solubility and stability. Cimzia must be dispensed with an FDA-approved Medication Guide.

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