Press release
OTEZLA® (APREMILAST) NOW AVAILABLE IN THE U.S. FOR MODERATE TO SEVERE PEDIATRIC PLAQUE PSORIASIS
First and Only Pill for Children and Adolescents Ages 6-17 with Moderate to Severe Plaque Psoriasis THOUSAND OAKS, Calif., Aug. 20, 2024 /PRNewswire/ -- Amgen
About this update from Amgen Inc.
[{"type":"text","content":"First and Only Pill for Children and Adolescents Ages 6-17 with Moderate to Severe Plaque Psoriasis\nTHOUSAND OAKS, Calif., Aug. 20, 2024 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced Otezla® (apremilast) is now available in the U.S. for pediatric use. Earlier this year, the U.S. Food and Drug Administration (FDA) approved Otezla for the treatment of moderate to severe plaque psoriasis in children and adolescents ages 6 and older who weigh at least 20 kg (44 lb) and are candidates for phototherapy or systemic therapy. There are currently no other FDA-approved oral medications for moderate to severe plaque psoriasis in this patient population.\n\"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,\" said Murdo Gordon, executive vice president of Global Commercial Operations at Amgen. \"In the last decade, Otezla has been prescribed to over one million adults worldwide, and today's announcement represents the potential for Otezla to offer relief to many younger patients.\"\n\"Children living with moderate to severe plaque psoriasis often experience uncomfortable and highly visible symptoms, such as itchy, dry lesions that may bleed or cause pain. However, treatment options for this chronic immune-mediated disease are limited,\" said Leah M. Howard, JD, president and CEO of the National Psoriasis Foundation. \"Until now, FDA-approved systemic treatment options for youth have been injections or infusions. The addition of an oral treatment option with a well-established safety profile is great news for children with this disease and their families.\"\nThe FDA approval was based on results from SPROUT, a Phase 3, multicenter, randomized, placebo-controlled, double-blind study which investigated the efficacy and safety of Otezla in pediatric patients aged 6 to 17 years with moderate to severe plaque psoriasis inadequately controlled by or intolerant to topical therapy. The primary endpoint – static Physician's Global Assessment (sPGA) response (defined as an sPGA score of clear [0] or almost clear [1] with at least a 2-point reduction from baseline) – at week 16 was met with a 33.1% sPGA response for Otezla versus 10.8% for placebo (95% CI: 12.2%, 32.4%; P","length":2948,"tagNa...