- Salix Pharmaceuticals introduces Rx topical foam to treat a form of inflammatory bowel disease
- Takeda starts phase-3 trials of vedolizumab
- FDA pushes back target date for review of Takeda drug in patients with ulcerative colitis
- Sandoz starts late-stage trial of Humira biosimilar
- FDA advisory committee recommends approval for Takeda's vedolizumab
WASHINGTON — A panel of outside advisers to the Food and Drug Administration has backed wider use for Abbott Labs’ rheumatoid arthritis drug, Humira, for treating a type of inflammatory bowel disease.
According to published reports, the panel voted 15-2 that the benefits of Humira outweighed the risks in treating ulcerative colitis. However, the panel asked Abbott to conduct more studies upon Humira's approval.
While it isn’t required to do so, the FDA typically follows panel recommendations. According to reports, a final decision is expected by the end of the year.
According to reports, the drug would only be used in people battling moderate to severe ulcerative colitis who have not had success with other medicines. If approved for ulcerative colitis, the drug maker said that Humira would be the first biologic drug that people could inject themselves.
Last November, the FDA rejected Abbott's application for Humira in ulcerative colitis, asking for further information.
The blockbuster drug already is approved for six other conditions, including rheumatoid arthritis and Crohn's disease.