Unanimous FDA panel support for Novartis’ secukinumab
October 21, 2014
Advisors to the US Food and Drug Administration have voted unanimously to support approval of Novartis’ secukinumab for moderate-to-severe plaque psoriasis.
The agency’s Dermatologic and Ophthalmic Drugs Advisory Committee voted 7-0 in favour of secukinumab, a selective interleukin-17A inhibitor, based on 10 Phase II/III clinical studies which included nearly 4,000 patients. Treatment with the drug has resulted in high rates of clear to almost clear skin at week 12 and it has shown superiority to Amgen’s Enbrel (etanercept), an anti-TNF standard of care.
Read more at: http://www.pharmatimes.com/Article/14-10-21/Unanimous_FDA_panel_support_for_Novartis_secukinumab.aspx#ixzz3Gr4vEmrq
Filed under: Uncategorized Tagged: novartis, Ophthalmic Drugs Advisory Committee, Secukinumab
