Novartis announced that the Dermatologic and Ophthalmic Drugs Advisory Committee (DODAC) has unanimously voted (7 to 0) to the Food and Drug Administration (FDA) in support of the approval of AIN457 (secukinumab) for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.
AIN457, a first-in-class human monoclonal antibody (mAb), selectively inhibits interleukin-17A (IL-17A), which inhibits the release of proinflammatory cytokines.
The Committee’s recommendation is based on the safety and efficacy data from ten psoriasis Phase 2/3 clinical studies that involved close to 4,000 patients with moderate-to-severe plaque psoriasis. In the Phase 3 clinical program, secukinumab met all primary and key secondary endpoints, including Psoriasis Area and Severity Index (PASI) 75 and 90, and Investigator’s Global Assessment modified 2011 0/1 responses. Secukinumab demonstrated significant skin clearance at Week 12. Further, a majority of the patients treated with secukinumab who achieved PASI 75 response and IGA mod 2011 0/1 at Week 12 also maintained their response at Week 52 with ongoing treatment.
A Biologics License Application (BLA) was submitted to the FDA in October 2013 with an FDA action anticipated for early 2015.
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