Biologic gets new indication for Crohn's disease
Adalimumab (Humira, Abbott) is now approved for a second indication for use by patients with moderately to severely active Crohn's disease who are not responding to conventional therapy to reduce signs and symptoms and induce and maintain clinical remission. The new approval was based on results from three clinical trials in more than 1,400 adult patients and evaluated the efficacy of adalimumab in patients who were naive to anti-tumor necrosis factor alpha therapy. According to Abbott, this approval marks the indication to launch with the Humira Pen, a method of self-injection approved by the FDA in June 2006. Adalimumab was previously approved for reducing the signs and symptoms and inducing clinical remission in patients who have lost response or have become intolerant to infliximab (Remicade, Centocor).
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FDA’s Recent Exemptions: What Do They Mean as We Finalize DSCSA Implementation?
October 31st 2024Kala Shankle, Vice President of Regulatory Affairs with the Healthcare Distribution Alliance, and Ilisa Bernstein, President of Bernstein Rx Solutions, LLC, discussed recent developments regarding the Drug Supply Chain Security Act.
