New Autoinjector for Prefilled, Single-Dose Enbrel Now Available in the U.S.

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by Alice Melao |

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A new reusable autoinjector system developed by Amgen for the administration of Enbrel (etanercept) is now available to patients in the United States.

The Enbrel Mini, with the AutoTouch delivery system, includes a sensor that detects the proximity of the skin, and it allows for better control over injection speed. It was approved by the U.S. Food and Drug Administration (FDA) in September.

The system received an Ease of Use Commendation from the Arthritis Foundation, which recognizes products that make life easier for those with arthritis or other medical conditions that limit physical capacities.

“We are happy to award the Enbrel Mini cartridge with AutoTouch reusable autoinjector with our Ease of Use Commendation,” Cindy McDaniel, senior vice president of consumer affairs at the Arthritis Foundation, said in a press release.

The Enbrel Mini single-dose prefilled cartridge with AutoTouch reusable autoinjector (PRNewsfoto/Amgen).

Enbrel is a tumor necrosis factor (TNF) inhibitor designed to reduce pain and inflammation associated with autoimmune diseases. It has been shown to be safe and effective in over 19 years of studies.

Enbrel was approved in the U.S for the treatment of rheumatoid arthritis in 1998, followed by additional extended approvals for the treatment of ankylosing spondylitis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, and plaque psoriasis.

“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, MD, 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,” Harper added.

The AutoTouch reusable system was designed to be used with Enbrel Mini single-dose, prefilled cartridges of 50 mg/mL, which uses a new formulation of the medicine.

The therapeutic potential of the new Enbrel formulation was tested in a Phase 3b study (NCT02986139). The study included 111 adult patients with moderate to severe rheumatoid arthritis and psoriatic arthritis and evaluated injection site pain.

The trial showed that in addition to leading to significantly lower pain at the injection site, the new formulation had a similar safety profile to that reported in previous studies.

These findings not only demonstrated that the new formulation was effective but also that the AutoTouch system could significantly reduce the burden of a common adversity of Enbrel therapy — injection site pain.