Amgen Inc and Wyeth Pharmaceuticals, a division of Wyeth, announced that Enbrel (etanercept) has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients (18 years or older) with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy. The psoriasis indication marks the fifth disease for which Enbrel has received an FDA approval in just over five years.
Psoriasis is a chronic immune disorder in which certain immune cells become overactive and release proteins called cytokines. Tumour necrosis factor (TNF) is one of those cytokines that helps regulate the body's immune response to infection and inflammation. In patients with psoriasis, TNF causes inflammation, which can lead to the formation of painful, often disfiguring psoriasis plaques. As an anti-TNF therapy, Enbrel binds to the over-produced TNF and renders it biologically inactive, which can result in a significant reduction in inflammation.
"Both physicians and patients have expressed a desire for new options to treat psoriasis. Enbrel rapidly cleared psoriasis in many patients and was generally well-tolerated in two large clinical trials," said Laura Hamill, vice president and general manager of Amgen's Inflammation Business Unit. "This approval in psoriasis, coupled with our previous indication in psoriatic arthritis, reinforces our commitment to dermatology and our core aspiration of providing treatments that can dramatically improve people's lives."
The approval was based on data from two Phase 3 studies totaling more than 1,200 adults with plaque psoriasis who were treated with Enbrel for up to 12 months. Enbrel was approved with a step-down dosing regimen of 50 mg administered twice-weekly for three months, followed by a maintenance dose of 50 mg weekly thereafter. Enbrel demonstrated rapid and significant clearing in many patients at this recommended dosing regimen. Patients who are treated with Enbrel require no routine laboratory monitoring specific to Enbrel therapy other than standard medical oversight.