The FDA today approved the monoclonal antibody secukinumab (Cosentyx) for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy, phototherapy, or both.
Secukinumab binds to interleukin-17, blocking this inflammatory cytokine's interaction with its receptor, according to manufacturer Novartis.
"Plaque psoriasis can cause significant skin irritation and discomfort for patients, so it is important to have a variety of treatment options available to patients," Amy Egan, MD, of the agency's Center for Drug Evaluation and Research, .
An FDA advisory committee had backed the drug's approval in an October 2014 vote.
The efficacy of secukinumab, given in monthly subcutaneous injections, was demonstrated in six phase III studies that included more than 2,400 patients.
In two of the trials, secukinumab was formulated as a lyophilized powder and given in doses of 150 or 300 mg. In the first, reductions of 75% in the Psoriasis Area and Severity Index (PASI75) were seen at 3 months in 82% and 71% of those given the higher and lower dose, respectively, compared with 4% of those given placebo. In the second, PASI75 responses were seen in 76%, 67%, and 5%.
In another study, the monoclonal antibody was provided in liquid pre-filled syringes, and 3-month PASI75 responses were achieved by 75% of the 300-mg group and 69% of the 150-mg group, but in none of the placebo group. The fourth study evaluated an autoinjector, with PASI75 responses being reported by 87% and 70% of the higher and lower dose group, and by 3% of the placebo group.
"The results seen from these clinical trials are increasing the efficacy bar compared with the data seen with previous psoriasis medications," said Mark Lebwohl, MD, of the department of dermatology at the Icahn School of Medicine at Mount Sinai in New York.
"Not only did record numbers of patients achieve 75% improvement ... but large numbers of patients in the studies were 100% clear. These are the best data we have for any drug for long-term therapy of this chronic disease," Lebwohl commented.
Patients will be provided with a medication guide advising them that secukinumab affects the immune system and therefore they may be at risk for infections. "Caution should be exercised when considering the use of Cosentyx in patients with a chronic infection or history of recurrent infection, and in patients with active Crohn's disease," FDA stated in the news release.
Approval of secukinumab came after the FDA's Advisory Committee unanimously voted for approval in October, and the more recent for plaque psoriasis.