FDA expands Janssen’s Stelara to cover adolescent psoriasis patients
pharmafile | October 16, 2017 | News story | Sales and Marketing | FDA, Janssen, Stelara, pharma, psoriasis
Janssen has announced that the FDA has approved an expanded indication for its psoriasis therapy Stelara (ustekinumab) for the treatment of moderate to severe plaque forms of the disease in adolescent patients aged 12 or over who are candidates for phototherapy or systemic therapy.
The decision was built upon Phase 3 data which demonstrated that Stelara produced response at a week 12 primary endpoint after subcutaneous administration of two doses at weeks 0 and 4, defined by achieving a Physician’s Global Assessment (PGA) score of 0 or 1, which relates to achievement of full clearance or minimal traces of the disease.
“Psoriasis can affect many aspects of everyday life and the visible plaques, itching and discomfort can take a particular toll on adolescents,” said Dr Andrew Greenspan, Vice President of Medical Affairs at Janssen. “With today’s approval, Stelara has the potential to make a meaningful difference in the lives of these young adults.”
Around 80-90% of psoriasis sufferers are affected by the plaque variation of the disease, and one-third of these individuals develop it before they turn 20. As there are limited treatment options in treating the illness within this age group, the FDA’s decision could mean big things for adolescents with psoriasis.
“Psoriasis is a highly visible disease, and it is essential that these younger patients and their caregivers have options that can effectively reduce the difficult-to-conceal and often misunderstood plaques,” said Dr Michael Siegel, Senior Vice President of Research and Clinical Affairs for the National Psoriasis Foundation. “It is encouraging to have new treatment options where few exist for adolescents living with psoriasis during such formative times in their lives.”
Matt Fellows
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