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Novartis - Secukinumab Early Data Impressive: Long Term Safety to determine the potential

October 2011 | 2 pages | ID: N6CCD5A6F3CEN
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NVS recently presented impressive PhII data for Secukinumab (AIN457, IL-17A inhibitor) in Plaque Psoriasis at annual European Academy of Dermatology and Venereology (EADV) congress. Data from three PhII studies were presented. The efficacy data is comparable to Humira or Cimzia, which currently are the most efficacious options among the marketed biologics for moderate to severe plaque psoriasis. On the safety front, Secukinumab was associated with a higher rate of serious adverse events (3% vs. 1%), while as far as the overall safety profile is concerned, Secukinumab was comparable to placebo. Safety is a major regulatory hurdle, as in the recent past Abbott’s compound Briakinumab (ABT-874, IL-12/23 inhibitor), despite showing best in class efficacy in plaque psoriasis was withdrawn, as FDA demanded longer term safety studies. In one of the pivotal PhIII studies, Briakinumab was associated with major adverse cardiovascular events (MACE).
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