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FDA Accepts Amgen's Supplemental Biologics License Application For The Expanded Use Of Enbrel® (Etanercept) To Treat Pediatric Patients With Chronic Severe Plaque Psoriasis
THOUSAND OAKS, Calif., March 10, 2016 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review Amgen's supplemental Biologics License Application (sBLA) for the expanded use of Enbrel® (etanercept) to treat pediatric patients with chronic severe plaque psoriasis.

"If approved, ENBREL would be the first systemic drug approved in the U.S. to treat chronic severe plaque psoriasis in pediatric patients," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "We hope to be able to provide pediatric patients with an important new treatment option where there is a clear unmet medical need."

The sBLA, submitted on Jan. 5, 2016, 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 with moderate to severe plaque psoriasis.

The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of Nov. 5, 2016, for the ENBREL sBLA application.
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Source: press release, 3/10/16. http://wwwext.amgen.com/media/news-releases/2016/03/fda-accepts-amgens-s...

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Compound/DeviceSpecialtyIndicationCompound ClassTarget
Etanercept Psoriasis pediatricRheumatologyPsoriasis chronic (pediatric)TNF-alpha receptor inhibitorTNF-alpha receptors

Mechanism of action: Etanercept is a dimeric soluble form of the p75 TNF receptor that can bind TNF molecules. Etanercept inhibits binding of TNF-α and TNF-β (lymphotoxin alpha [LT-α]) to cell surface TNFRs, rendering TNF biologically inactive. TNF is a naturally occurring cytokine that is involved in normal inflammatory and immune responses. It plays an important role in the inflammatory processes of RA, polyarticular JIA, PsA, and AS and the resulting joint pathology. In addition, TNF plays a role in the inflammatory process of PsO. Elevated levels of TNF are found in involved tissues and fluids of patients with RA, JIA, PsA, AS, and PsO.

Phase of Development: Filed

Event Type: Regulatory FDA: PDUFA DATE

Dates: 2016-11-05

Results:

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FDA Approves Expanded Use Of ENBREL® (etanercept) To Treat Children With Chronic Moderate-To-Severe Plaque Psoriasis

First and Only Systemic Drug Approved in the U.S. to Treat Children Affected by This Serious Inflammatory Disease

THOUSAND OAKS, Calif., Nov. 4, 2016 /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.

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"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."
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Source: press release, 11/05/16. http://wwwext.amgen.com/media/news-releases/2016/11/fda-approves-expande...

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