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    New Combination Product for Symptoms of Seasonal Allergic Rhinitis Approved by US FDA with Aptar Pharma’s VP3 Nasal Spray System

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Amgen Launches The ENBREL Mini™ Single-Dose Prefilled Cartridge With AutoTouch™ Reusable Autoinjector That Is Ergonomically Designed For Patients

Yuvraj_pawp by Yuvraj_pawp
17th November 2017
in Facilities & Operation

Amgen announced that the ENBREL Mini with AutoTouch™ is now available in the United States (U.S.). Awarded the Arthritis Foundation Ease of UseSM Commendation, this new and innovative delivery system provides an additional administration option for appropriate ENBREL patients.

The AutoTouch™ reusable autoinjector has an ergonomic design that includes features that were designed with patients in mind, including an ergonomic handle, a needle designed to stay hidden during the injection, a sensor to detect placement on skin, a speed switch with three injection speeds, a progress bar and a speaker. The AutoTouch™ reusable autoinjector is used with ENBREL Mini™ single-dose prefilled cartridges (50 mg/mL) that utilize a new drug formulation of ENBREL that was associated with substantially significant lower mean injection site pain than the current formulation.

Enbrel Mini™ single-dose prefilled cartridge with AutoTouch™ reusable autoinjector
“As a leader in the inflammation space, we continually strive to innovate to address real needs among the patients we serve. The first step in this is talking and listening to the community, both patients and healthcare professionals, to fully understand the challenges they are facing,” said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. “These conversations highlighted the value of features that we believe enhance the patient experience. From there, the ENBREL Mini™ with AutoTouch™ and the new formulation, were born.”

ENBREL is an injectable biologic approved for the treatment of several chronic conditions including moderate-to-severe rheumatoid arthritis (RA), moderate-to-severe polyarticular juvenile idiopathic arthritis (JIA), psoriatic arthritis (PsA), ankylosing spondylitis (AS) and moderate-to-severe plaque psoriasis (PsO) in patients four years or older.

“We are happy to award the ENBREL Mini™ cartridge with AutoTouch™ reusable autoinjector with our Ease of UseSM Commendation,” said Cindy McDaniel, senior vice president, Consumer Affairs, The Arthritis Foundation. “This distinction is awarded to products proven to help people who have arthritis and other physical limitations.”

The ENBREL Mini™ with AutoTouch™ was approved by the U.S. Food and Drug Administration in September 2017.

A Phase 3b multicenter, randomized, double-blind, crossover study was conducted to assess the injection site pain associated with a modified etanercept formulation in adult patients with either moderate-to-severe RA or PsA. In addition to demonstrating a significant reduction in injection site pain, the adverse events were similar to those seen in previous studies in adults with moderate-to-severe RA and PsA.

About Enbrel® (etanercept)
ENBREL is a soluble form of a tumor necrosis factor (TNF) receptor with a clinical efficacy and safety profile established over 19 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, in 2004 to treat moderate-to-severe plaque psoriasis in adults, and in 2016 the moderate-to-severe plaque psoriasis indication was expanded to include patients 4 years or older. Prescription ENBREL is given by injection.

CONTACT: Amgen, Thousand Oaks
Kristen Davis, 805-447-3008 (media)
Kristen Neese, 805-313-8267 (media)
Arvind Sood, 805-447-1060 (investors)

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