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The U.S. Food and Drug Administration has approved secukinumab for the treatment of moderate to severe plaque psoriasis in adults.
The injectable interleukin-17A inhibitor is indicated for psoriasis patients who are candidates for systemic therapy and/or phototherapy, according to a press release from the FDA. Novartis Pharmaceuticals will market secukinumab as Cosentyx.
The Jan. 21 approval was based on data from randomized, placebo-controlled clinical trials involving 2,403 patients. The most common side effects reported in the trials included upper respiratory infections and diarrhea.
The biologic is being approved with a medication guide “to inform patients that, because Cosentyx is a medicine that affects the immune system, patients may have a greater risk of getting an infection,” according to the FDA release. Consequently, the FDA advised clinicians to be cautious when prescribing secukinumab to patients with chronic or recurrent infections, and to those with active Crohn’s disease.
The FDA approval followed an advisory committee meeting in October 2014.
The U.S. Food and Drug Administration has approved secukinumab for the treatment of moderate to severe plaque psoriasis in adults.
The injectable interleukin-17A inhibitor is indicated for psoriasis patients who are candidates for systemic therapy and/or phototherapy, according to a press release from the FDA. Novartis Pharmaceuticals will market secukinumab as Cosentyx.
The Jan. 21 approval was based on data from randomized, placebo-controlled clinical trials involving 2,403 patients. The most common side effects reported in the trials included upper respiratory infections and diarrhea.
The biologic is being approved with a medication guide “to inform patients that, because Cosentyx is a medicine that affects the immune system, patients may have a greater risk of getting an infection,” according to the FDA release. Consequently, the FDA advised clinicians to be cautious when prescribing secukinumab to patients with chronic or recurrent infections, and to those with active Crohn’s disease.
The FDA approval followed an advisory committee meeting in October 2014.
The U.S. Food and Drug Administration has approved secukinumab for the treatment of moderate to severe plaque psoriasis in adults.
The injectable interleukin-17A inhibitor is indicated for psoriasis patients who are candidates for systemic therapy and/or phototherapy, according to a press release from the FDA. Novartis Pharmaceuticals will market secukinumab as Cosentyx.
The Jan. 21 approval was based on data from randomized, placebo-controlled clinical trials involving 2,403 patients. The most common side effects reported in the trials included upper respiratory infections and diarrhea.
The biologic is being approved with a medication guide “to inform patients that, because Cosentyx is a medicine that affects the immune system, patients may have a greater risk of getting an infection,” according to the FDA release. Consequently, the FDA advised clinicians to be cautious when prescribing secukinumab to patients with chronic or recurrent infections, and to those with active Crohn’s disease.
The FDA approval followed an advisory committee meeting in October 2014.
