20/08/2024 | Press release | Distributed by Public on 20/08/2024 20:18
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%; P<0.0001). The adverse events were consistent with the known safety profile of Otezla in adult patients.
The most common side effects of Otezla include diarrhea, nausea, upper respiratory tract infection, tension headache and headache.
After the initial titration period, the maintenance dosage of Otezla in this patient group will be administered in either 20 or 30 mg doses, based on weight, twice daily. The recommended dose is 20 mg twice daily for pediatric patients weighing 20 kg to <50 kg, and 30 mg twice daily for those who weigh at least 50 kg.
Amgen is committed to supporting plaque psoriasis patients to ensure that appropriate patients have affordable access to Otezla. For more information, please visit Otezla.com.
About Psoriasis
Psoriasis is a chronic disease where skin cells build up quickly, typically causing red or discolored, scaly, and itchy patches on the skin.1 Approximately 125 million people worldwide have psoriasis, including around 14 million people in Europe and more than 8 million people in the United States.2,3 About 80% of those patients have plaque psoriasis.4 Among pediatric patients with plaque psoriasis, one in five have moderate to severe disease.5 Approximately one-third of those who get psoriasis are under 18 years old when the disease first surfaces.6
About Otezla® (apremilast)
Otezla® (apremilast) is an oral small-molecule inhibitor of phosphodiesterase 4 (PDE4) specific for cyclic adenosine monophosphate (cAMP). PDE4 inhibition results in increased intracellular cAMP levels, which is thought to indirectly modulate the production of inflammatory mediators. The specific mechanism(s) by which Otezla exerts its therapeutic action in patients is not well defined.
Since its initial FDA approval in 2014, Otezla has been prescribed to more than 1 million patients worldwide.7
INDICATIONS
Otezla® (apremilast) is indicated for the treatment of:
IMPORTANT SAFETY INFORMATION
Contraindications
Warnings and Precautions
Adverse Reactions
Use in Specific Populations
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., Ltd.), the performance of Otezla® (apremilast) (including anticipated Otezla sales growth and the timing of non-GAAP EPS accretion), our acquisitions of Teneobio, Inc., ChemoCentryx, Inc., or Horizon Therapeutics plc (including the prospective performance and outlook of Horizon's business, performance and opportunities, any potential strategic benefits, synergies or opportunities expected as a result of such acquisition, and any projected impacts from the Horizon acquisition on our acquisition-related expenses going forward), as well as estimates of revenues, operating margins, capital expenditures, cash, other financial metrics, expected legal, arbitration, political, regulatory or clinical results or practices, customer and prescriber patterns or practices, reimbursement activities and outcomes, effects of pandemics or other widespread health problems on our business, outcomes, progress, and other such estimates and results. Forward-looking statements involve significant risks and uncertainties, including those discussed below and more fully described in the Securities and Exchange Commission reports filed by Amgen, including our most recent annual report on Form 10-K and any subsequent periodic reports on Form 10-Q and current reports on Form 8-K. Unless otherwise noted, Amgen is providing this information as of the date of this news release and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise.
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CONTACT: Amgen, Thousand Oaks
Elissa Snook, 609-251-1407 (media)
Kate Meyer, 872-867-0754 (media)
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References
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