US regulators have approved an expansion of Johnson & Johnson’s Stelara to include younger patients with plaque psoriasis.
The drug can now be prescribed by physicians to treat patients aged 12 years and above with moderate to severe plaque psoriasis, offering an new treatment option for this age group.
J&J says the approval is a milestone for younger patients as around one-third of individuals who develop plaque psoriasis do so before 20 years of age, but there are limited treatment options for them.
“Psoriasis can affect many aspects of everyday life and the visible plaques, itching and discomfort can take a particular toll on adolescents,” said Andrew Greenspan, vice president of Medical Affairs at Janssen. With this new approval, “Stelara has the potential to make a meaningful difference in the lives of these young adults.”
The decision rides on the back data from a Phase III study in which at least two-thirds of patients receiving Stelara were responders at the week 12 primary endpoint after just two doses at weeks 0 and 4, defined by achieving a Physician’s Global Assessment (PGA) score of 0 or 1 (cleared or minimal psoriasis).
Stelara (ustekinumab) was approved for use in patients with the condition aged 12 and over in Europe back in 2013.