BioCentury
ARTICLE | Regulation

Weighing IL-17

FDA panel backs Novartis' Cosentys for psoriasis but wants dosing, SAE data

October 27, 2014 7:00 AM UTC

Cosentyx secukinumab appears poised to become the first of the IL-17 targeted mAbs to reach the market. But it remains to be seen how much work FDA will ask Novartis AG to take on postmarket to satisfy lingering safety concerns and potentially give doctors the option of an even higher dose.

Last week, FDA's Dermatologic and Ophthalmic Drugs Advisory Committee voted 7-0 to recommend approval of the human IgG1 mAb targeting interleukin-17A (IL-17A) to treat adult patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy...