We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies, revised Privacy Policy and Terms of Service.
You are being directed to ZacksTrade, a division of LBMZ Securities and licensed broker-dealer. ZacksTrade and Zacks.com are separate companies. The web link between the two companies is not a solicitation or offer to invest in a particular security or type of security. ZacksTrade does not endorse or adopt any particular investment strategy, any analyst opinion/rating/report or any approach to evaluating individual securities.
If you wish to go to ZacksTrade, click OK. If you do not, click Cancel.
Lilly's Taltz Gets FDA Nod for Plaque Psoriasis in Children
Read MoreHide Full Article
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.
In addition to the stocks discussed above, would you like to know about our 10 finest buy-and-hold tickers for the entirety of 2020?
Last year's 2019 Zacks Top 10 Stocks portfolio returned gains as high as +102.7%. Now a brand-new portfolio has been handpicked from over 4,000 companies covered by the Zacks Rank. Don’t miss your chance to get in on these long-term buys.
Image: Bigstock
Lilly's Taltz Gets FDA Nod for Plaque Psoriasis in Children
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.
Zacks Top 10 Stocks for 2020
In addition to the stocks discussed above, would you like to know about our 10 finest buy-and-hold tickers for the entirety of 2020?
Last year's 2019 Zacks Top 10 Stocks portfolio returned gains as high as +102.7%. Now a brand-new portfolio has been handpicked from over 4,000 companies covered by the Zacks Rank. Don’t miss your chance to get in on these long-term buys.
Access Zacks Top 10 Stocks for 2020 today >>