J&J's Psoriasis Drug Stelara Gets FDA Nod For Adolescent Use
Zacks Investment Research | Oct 15, 2017 09:38PM ET
Janssen, a subsidiary of Johnson & Johnson (NYSE:JNJ) , announced that the FDA has approved the label expansion of its plaque psoriasis drug, Stelara for use in adolescents (12 years of age or older). The drug is approved for adults in this indication since 2009.
The company believes that the label expansion is a significant achievement as plaque psoriasis develops before the age of 20 years in approximately one-third of the patients. Moreover, the number of treatments available for adolescents is limited.
Patients are administered only four doses a year after two starter doses of Stelara, which has become a leading therapeutic option.
Shares of the company are up 18.4% so far this year, almost in line with the industry ’s performance. The industry has gained 18.3% in the same time frame.
The latest approval for Stelara is based on data from a phase III study, which evaluated the subcutaneous administration of the drug in adolescent patients. The data showed that the drug achieved minimal psoriasis or clear skin in at least two-thirds of the patients. The safety data was also consistent with what was achieved in adult patients.
There are almost 7.5 million people suffering from psoriasis in the United States per the American Academy of Dermatology. Moreover, the National Center for Biotechnology Information stated that the majority of psoriasis patients suffer from plaque psoriasis. The numbers represent a huge opportunity for the drug following its label expansion..
Moreover, with this approval Stelara has gained an edge over competing drugs like AbbVie Inc.’s (NYSE:ABBV) Humira, Novartis AG’s Cosentyx and Celgene Corporation’s (NASDAQ:CELG) Otezla, which are only approved for adult plaque psoriasis patients. However, Pfizer Inc.’s (NYSE:PFE) Enbrel will compete with Stelara in the adolescent segment.
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