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 (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.
"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." "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." The 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%; P5% was reported in 4.9% (5/103) of patients taking Otezla and in 3.9% (4/102) of patients taking placebo Drug Interactions: Apremilast exposure was decreased when Otezla was co-administered with rifampin, a strong CYP450 enzyme inducer; loss of Otezla efficacy may occur.
Concomitant use of Otezla with CYP450 enzyme inducers (e.g., rifampin, phenobarbital, carbamazepine, phenytoin) is not recommended Adverse Reactions Plaque Psoriasis : The most common adverse reactions (≥ 5%) are diarrhea, nausea, upper respiratory tract infection, and headache, including tension headache.
Overall, the safety profile of Otezla in adult patients with mild to moderate plaque psoriasis and pediatric patients with moderate to severe plaque psoriasis was consistent with the safety profile established in adult patients with moderate to severe plaque psoriasis Psoriatic Arthritis : The most common adverse reactions (≥ 5%) are diarrhea, nausea, and headache Behçet's Disease : The most common adverse reactions (≥ 10%) are diarrhea, nausea, headache, and upper respiratory tract infection Use in Specific Populations Otezla has not been studied in pregnant women. Advise pregnant women of the potential risk of fetal loss Please click here for the full Prescribing Information for Otezla . About Amgen Amgen discovers, develops, manufactures and delivers innovative medicines to help millions of patients in their fight against some of the world's toughest diseases.
More than 40 years ago, Amgen helped to establish the biotechnology industry and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what's known today. Amgen is advancing a broad and deep pipeline that builds on its existing portfolio of medicines to treat cancer, heart disease, osteoporosis, inflammatory diseases and rare diseases. In 2024, Amgen was named one of the "World's Most Innovative Companies" by Fast Company and one of "America's Best Large Employers" by Forbes, among other external recognitions .
Amgen is one of the 30 companies that comprise the Dow Jones Industrial Average ® , and it is also part of the Nasdaq-100 Index ® , which includes the largest and most innovative non-financial companies listed on the Nasdaq Stock Market based on market capitalization. For more information, visit Amgen.com and follow Amgen on X , LinkedIn , Instagram , TikTok , YouTube and Threads .
Amgen Forward-Looking Statements This news release contains forward-looking statements that are based on the current expectations and beliefs of Amgen. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including any statements on the outcome, benefits and synergies of collaborations, or potential collaborations, with any other company (including BeiGene, Ltd. or Kyowa Kirin Co.
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