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Lilly's Taltz Gets FDA Nod for Plaque Psoriasis in Children

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Eli Lilly and Company (LLY - Free Report) announced that the FDA has approved a supplemental biologics license application (sBLA) for its psoriasis drug Taltz (ixekizumab). Taltz injection (80 mg/mL) is now approved for the treatment of pediatric patients (aged from six to below 18 years) with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

Following this nod, Taltz became the first and the only IL-17A antagonist to be approved to treat the given patient population.

Taltz was evaluated in a randomized, placebo-controlled phase III study, which demonstrated its efficacy, tolerability and safety in 171 pediatric patients with moderate to severe plaque psoriasis. Taltz achieved the co-primary efficacy endpoint, which was to see the proportion of patients achieving 75% improvement from baseline in their Psoriasis Area and Severity Index score (PASI 75) response at 12 weeks of treatment compared to placebo.

Per the press release, the proportion of patients achieving the co-primary endpoints was superior to placebo with a statistically significant difference. Moreover, Taltz also met all the major secondary endpoints in the given study.

Shares of Lilly inched up 3.2% following this news on Monday. In fact, the stock has rallied 7.3% in the past year against the industry’s decrease of 10.3%.

Taltz is presently marketed for moderate-to-severe plaque in adults who are the candidates for systemic therapy or phototherapy and also for addressing patients with active psoriatic arthritis (PsA). In August 2019, the FDA approved Taltz for treating adult patients with ankylosing spondylitis (AS), also known as radiographic axial spondyloarthritis (r-axSpA).

We note that Taltz is an important revenue driver for Lilly, generating worldwide sales of $1.4 billion in 2019. The figure is up 46% year over year. The label expansion will broaden the drug’s eligible patient population, which in turn, should drive its sales going forward.

However, competition remains a major concern for Lilly. Notably, apart from Taltz, other drugs having got the nod to treat plaque psoriasis are Novartis’ (NVS - Free Report) Cosentyx, AbbVie’s (ABBV - Free Report) Humira and Johnson & Johnson’s (JNJ - Free Report) Tremfya.

Zacks Rank

Lilly currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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