Otezla available in US for treatment of plaque psoriasis in children, adolescents
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Key takeaways:
- Otezla is now available in the U.S. to treat children and adolescents with moderate to severe plaque psoriasis.
- Otezla was approved earlier this year.
Otezla is now available in the U.S. for the treatment of moderate to severe plaque psoriasis in children and adolescents aged 6 years and older, Amgen announced in a press release.
Otezla (apremilast), an oral small-molecule inhibitor of phosphodiesterase 4, was FDA-approved earlier this year for the treatment of moderate to severe plaque psoriasis in children and adolescents aged 6 years and older who weigh at least 44 lbs and are candidates for phototherapy or systemic therapy. This decision made Otezla the first oral medication approved in this indication for this patient population.
“For the first time, children and adolescents with moderate to severe plaque psoriasis and their caregivers have an oral option to treat this chronic disease, with its highly visible, uncomfortable symptoms,” Murdo Gordon, BS, executive vice president of global commercial operations at Amgen, said in the release.
The approval was supported by results from SPROUT, a phase 3, multicenter, randomized, placebo-controlled, double-blind study, which showed that 33.1% of patients treated with Otezla achieved a static Physician Global Assessment response vs. 10.8% of placebo-treated patients (P < .0001).
According to the release, patients will receive either 20 mg or 30 mg twice-daily doses based on weight following the initial titration period. The company reports that it will be working to ensure that patients have affordable access to Otezla.
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