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Results of Phase III trials involving AbbVie’s blockbuster drug Humira (adalimumab) for the treatment of noninfectious uveitis were released on Sept 7, 2016. FDA approved the drug for noninfectious intermediate, posterior, and panuveitis in June 2016, bringing Humira’s list of approved US indications to 10.
Results of Phase III trials involving AbbVie’s blockbuster drug Humira (adalimumab) for the treatment of noninfectious uveitis were released on Sept 7, 2016. FDA approved the drug for noninfectious intermediate, posterior, and panuveitis in June 2016, bringing Humira’s list of approved US indications to 10. FDA also granted the drug orphan drug designation in 2014 for certain forms of uveitis, which affects fewer than 200,000 patients in the United States, AbbVie said in a press announcement.
According to the National Eye Institute, uveitis is an inflammatory eye disease that damages eye tissue. In some cases, uveitis can lead to reduced vision or vision loss. Corticosteroids and immunosuppressive treatments can be used to treat the uveitis. Adalimumab is currently the only non-corticosteroid therapy approved for the disease, AbbVie said.
Patients in the adalimumab trial received an 80-mg dose of adalimumab followed by a dose of 40 mg every two weeks, or subsequent placebo. According to the study, published in the New England Journal of Medicine, 68% of patients involved in the trial achieved clinical success after 10 weeks of treatment. However, the study notes, “more than half the patients had treatment failure by 80 weeks.” Adalimumab was effective at delaying “uveitic flares in the majority of eyes but, as expected, did not ‘cure’ the patient’s uveitis.” Overall, researchers say, the drug reduced the risk of uveitic flare or visual impairment.
Adalimumab’s orphan drug status for the treatment of uveitis gives AbbVie patent exclusivity for seven years for this indication. This may prove important for the company as competitors work to bring adalimumab biosimilars to market. In early July 2016, Amgen’s ABP 501 biosimilar received a positive recommendation from an FDA panel who said the biosimilar was “highly similar” to adalimumab. Amgen plans to have its first biosimilar on the market between 2017 and 2019, but faced setbacks when the US Patent Office refused to review two of Humira’s formulation patents.
Source: New England Journal of Medicine, FDA, AbbVie