First and Only Systemic Drug Approved in the U.S. to Treat Children Affected by This Serious Inflammatory Disease
THOUSAND OAKS, Calif. /PRNewswire/ -- Amgen (NASDAQ: AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for the expanded use of ENBREL® (etanercept), making it the first and only systemic therapy to treat pediatric patients (ages 4-17) with chronic moderate-to-severe plaque psoriasis.
"As many parents of children with moderate-to-severe plaque psoriasis can tell you, there is a need for FDA approved systemic therapies in the pediatric setting. Until now, no biologics — which are effective in treating adults with moderate-to-severe plaque psoriasis — had been approved in the U.S. for the treatment of moderate-to-severe plaque psoriasis in children," said Randy Beranek, president and chief executive officer of the National Psoriasis Foundation. "This new approval is an important development for this patient community, as well as their parents and families, and marks a significant milestone in advancing the treatment of children living with this devastating disease."
The approval is based on results from a Phase 3 one-year study and its five-year open-label extension study to evaluate the safety and efficacy of ENBREL in pediatric patients, ages 4 to 17, with chronic moderate-to-severe plaque psoriasis. In addition to demonstrating significant efficacy, the adverse events were similar to those seen in previous studies in adults with moderate-to-severe plaque psoriasis.
"The need for an effective treatment for chronic moderate-to-severe pediatric psoriasis patients is high, and safety is always a concern when it comes to treating children. ENBREL has over a decade of experience in adult moderate to severe plaque psoriasis, and that proven track record matters to healthcare professionals, as well as the parents of children with moderate-to-severe plaque psoriasis," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "Today's FDA approval shows that innovation doesn't stop with a drug's first market approval, and further reflects Amgen's commitment to continually unlock and expand the therapeutic potential of our medicines in the hopes of filling unmet patient needs."
Learn more about this expanded use of ENBREL at www.enbrel.com or by calling 1-888-4ENBREL.
Psoriasis is a serious, chronic inflammatory disease that causes raised, red, scaly patches to appear on the skin, typically affecting the outside of the elbows, knees or scalp, though it can appear on any location.1,2 Approximately 125 million people worldwide have psoriasis and 80 percent of those patients have plaque psoriasis.3,4 About one-third of psoriasis cases are pediatric.5
About ENBREL® (etanercept)
ENBREL is a soluble form of a tumor necrosis factor (TNF) receptor with a clinical efficacy and safety profile established over 15 years of collective clinical experience. ENBREL was first approved in 1998 for moderate-to-severe rheumatoid arthritis. ENBREL was approved in 1999 to treat moderate-to-severe polyarticular juvenile idiopathic arthritis, in 2002 to treat psoriatic arthritis, in 2003 for the treatment of patients with ankylosing spondylitis, and in 2004 to treat moderate-to-severe plaque psoriasis in adults. Prescription ENBREL is given by injection.
ENBREL indications in the U.S.:
ENBREL U.S. Important Safety Information
Patients treated with ENBREL are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids or were predisposed to infection because of their underlying disease. ENBREL should not be initiated in the presence of sepsis, active infections, or allergy to ENBREL or its components. ENBREL should be discontinued if a patient develops a serious infection or sepsis. Reported infections include: 1) Active tuberculosis (TB), including reactivation of latent TB. Patients with TB have frequently presented with disseminated or extrapulmonary disease. Patients should be tested for latent TB before ENBREL use and periodically during therapy. Treatment for latent infection should be initiated prior to ENBREL use, 2) Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Patients with histoplasmosis or other invasive fungal infections may present with disseminated, rather than localized, disease. Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection. Empiric antifungal therapy should be considered in patients at risk for invasive fungal infections who develop severe systemic illness, and 3) Bacterial, viral, and other infections due to opportunistic pathogens, including Legionella and Listeria.
The risks and benefits of treatment with ENBREL should be carefully considered prior to initiating therapy in patients 1) with chronic or recurrent infection, 2) who have been exposed to TB, 3) who have resided or traveled in areas of endemic TB or endemic mycoses, or 4) with underlying conditions that may predispose them to infections such as advanced or poorly controlled diabetes. Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with ENBREL, including the possible development of TB in patients who tested negative for latent TB prior to initiating therapy.
Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with tumor necrosis factor (TNF) blockers, including ENBREL.
In adult clinical trials of all TNF blockers, more cases of lymphoma were seen compared to control patients. The risk of lymphoma may be up to several-fold higher in RA patients. The role of TNF blocker therapy in the development of malignancies is unknown. Cases of acute and chronic leukemia have been reported in association with postmarketing TNF blocker use in RA and other indications. The risk of leukemia may be higher in patients with RA (approximately 2-fold) than the general population. Melanoma and non-melanoma skin cancer (NMSC) have been reported in patients treated with TNF blockers, including ENBREL. Periodic skin examinations should be considered for all patients at increased risk for skin cancer. In patients who initiated therapy at ≤ 18 years of age, approximately half of the reported malignancies were lymphomas (Hodgkin's and non-Hodgkin's lymphoma). Other cases included rare malignancies usually associated with immunosuppression and malignancies that are not usually observed in children and adolescents. Most of the patients were receiving concomitant immunosuppressants.
Treatment with TNF-blocking agents, including ENBREL, has been associated with rare (< 0.1%) cases of new onset or exacerbation of central nervous system demyelinating disorders, some presenting with mental status changes and some associated with permanent disability, and with peripheral nervous system demyelinating disorders. Cases of transverse myelitis, optic neuritis, multiple sclerosis, Guillain-Barré syndromes, other peripheral demyelinating neuropathies, and new onset or exacerbation of seizure disorders have been reported in postmarketing experience with ENBREL therapy. Prescribers should exercise caution in considering the use of ENBREL in patients with preexisting or recent-onset central or peripheral nervous system demyelinating disorders.
Cases of worsening congestive heart failure (CHF) and, rarely, new-onset cases have been reported in patients taking ENBREL. Caution should be used when using ENBREL in patients with CHF. These patients should be carefully monitored. Rare cases of pancytopenia, including aplastic anemia, some fatal, have been reported. The causal relationship to ENBREL therapy remains unclear. Exercise caution when considering ENBREL in patients who have a previous history of significant hematologic abnormalities. Advise patients to seek immediate medical attention if they develop signs or symptoms of blood dyscrasias or infection. Consider discontinuing ENBREL if significant hematologic abnormalities are confirmed. Reactivation of hepatitis B has been reported in patients who were previously infected with hepatitis B virus (HBV) and received concomitant TNF-blocking agents, including ENBREL. Most reports occurred in patients also taking immunosuppressive agents, which may contribute to hepatitis B reactivation. Exercise caution when considering ENBREL in these patients.
Allergic reactions associated with administration of ENBREL during clinical trials have been reported in < 2% of patients. If an anaphylactic reaction or other serious allergic reaction occurs, administration of ENBREL should be discontinued immediately and appropriate therapy initiated. Live vaccines should not be administered to patients on ENBREL. Pediatric patients, if possible, should be brought up to date with all immunizations prior to initiating ENBREL. In patients with exposure to varicella virus, temporarily discontinue ENBREL and consider prophylactic treatment with Varicella Zoster Immune Globulin. Autoantibodies may develop with ENBREL, and rarely lupus-like syndrome or autoimmune hepatitis may occur. These may resolve upon withdrawal of ENBREL. Stop ENBREL if lupus-like syndrome or autoimmune hepatitis develops. The use of ENBREL in patients with Wegener's granulomatosis receiving immunosuppressive agents (e.g., cyclophosphamide) is not recommended. Based on a study of patients treated for alcoholic hepatitis, exercise caution when using ENBREL in patients with moderate-to-severe alcoholic hepatitis.
The most commonly reported adverse reactions in RA clinical trials were injection site reaction and infection. In clinical trials of all other adult indications, adverse reactions were similar to those reported in RA clinical trials. In general, the adverse reactions in pediatric patients were similar in frequency and type as those seen in adult patients. The types of infections reported in pediatric patients were generally mild and consistent with those commonly seen in the general pediatric population.
Please see Prescribing Information and Medication Guide at www.ENBREL.com
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1 National Psoriasis Foundation. Symptoms and diagnosis. http://www.psoriasis.org/about-psoriasis/symptoms-and-diagnosis. Accessed on October 3, 2016.
2 National Psoriasis Foundation. Frequently Asked Questions. http://www.psoriasis.org/about-psoriasis/faqs. Accessed on October 3, 2016.
3 International Federation of Psoriasis Associations. Psoriasis is a Serious Disease Deserving Global Attention: A report by the International Federation of Psoriasis Associations. www.ifpa-pso.org/getfile.ashx?cid=279366&cc=3&refid=18. Accessed on October 3, 2016.
4 American Academy of Dermatology. Psoriasis. http://www.aad.org/media-resources/stats-and-facts/conditions/psoriasis. Last updated 2014. Accessed on October 3, 2016.
5 Raychaudhuri SP, Gross J. A comparative study of pediatric onset psoriasis with adult onset psoriasis.http://www.ncbi.nlm.nih.gov/pubmed/10886746 Accessed on October 3, 2016.
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