FDA has approved Cosentyx (secukinumab) for two new indications: the treatment of adult patients with active ankylosing spondylitis (AS) and active psoriatic arthritis (PsA).

Indications: Cosentyx is a human interleukin-17A antagonist indicated for the treatment of:

• Adults with active AS.

• Adults with active PsA.

• Moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy.

Dosage and administration: Administer with or without a loading dosage. The recommended dosage:

• With a loading dosage:150 mg at weeks 0, 1, 2, 3, and 4 and every 4 weeks thereafter.

• Without a loading dosage: 150 mg every 4 weeks.

Efficacy and safety: The approvals are based on the efficacy and safety outcomes from 2 AS and 2 PsA placebo-controlled Phase III studies that included more than 1,500 individuals. Cosentyx achieved statistically significant improvements vs placebo in the signs and symptoms of AS and PsA.

Side effects/risks: Most common adverse reactions are nasopharyngitis, diarrhea, and upper respiratory tract infection.

Citation: Novartis receives two new FDA approvals for Cosentyx (secukinumab) to treat patients with ankylosing spondylitis and psoriatic arthritis. [news release]. East Hanover, NJ: Novartis Pharmaceuticals; January 15, 2016. http://www.multivu.com/players/English/7728651-cosentyx-fda-approval/. Accessed January 24, 2016.

Cosentyx [package insert]. East Hanover, NJ: Novartis Pharmaceuticals; 2016. http://www.pharma.us.novartis.com/product/pi/pdf/cosentyx.pdf. Accessed January 24, 2016.