Novartis AG — Cosentyx FDA Review (BLA125504, ORIG 1, 2015)

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The FDA clinical review recommends approval for Novartis's Cosentyx (secukinumab) at both 150 mg and 300 mg doses for moderate to severe plaque psoriasis in adults, with the 300 mg dose showing slightly higher efficacy. The review is based on four Phase 3 trials (CAIN457A2302, CAIN457A2303, CAIN457A2308, CAIN457A2309) assessing efficacy and safety at 12 and 52 weeks, comparing secukinumab against placebo and etanercept. Efficacy, including PASI 75 and IGA 0/1 response rates, was evaluated across doses and body weight groups, noting the impact of body weight on exposure and efficacy. The safety profile, including deaths, SAEs, infections, autoimmune events, and MACE, was generally favorable. While overall mortality risk was not increased, some infections showed a dose-response relationship, particularly with the 300 mg dose in lighter patients. Immunogenicity was low and did not impact efficacy or safety. No significant cardiovascular safety concerns were identified. Post-marketing commitments for malignancy monitoring and drug-drug interaction studies were recommended.

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