Amgen‘s Enbrel Mini with AutoTouch is now available in the United States for the treatment of chronic conditions like polyarticular juvenile idiopathic arthritis (JIA), rheumatoid arthritis, and other conditions.
Enbrel (etanercept) is a soluble form of tumor necrosis factor (TNF) with a demonstrated clinical effectiveness and safety profile. Enbrel was first approved by the U.S. Food and Drug Administration (FDA) for the treatment of JIA in 1999 in patients ages 2 and older.
Now, this new delivery system offers patients a new administration option for Enbrel.
The AutoTouch reusable autoinjector was created with an ergonomic design that includes a handle, a needle that remains hidden during the injection, a sensor to detect its placement on the skin, three injection speed levels, a progress bar, and a speaker.
The autoinjector is used with Enbrel Mini single-dose prefilled cartridges (50 mg/mL) that have a new formulation of Enbrel, which is associated with lower injection site pain when compared to the current formula.
“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,” Sean E. Harper, MD, executive vice president of research and development at Amgen, said in a press release.
“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.
Results from a Phase 3b, double-blind, multi-center study (NCT02986139), conducted to assess the injection site pain associated with the new Enbrel formulation in adults with rheumatoid arthritis and psoriatic arthritis, supported its use. The trial showed that besides a reduction in pain at the injection site, adverse events were similar to those seen in previous studies.
The Enbrel Mini with AutoTouch was approved by the FDA in September 2017. The device was also awarded the Arthritis Foundation Ease of Use Commendation for providing an additional administration option for Enbrel.
“We are happy to award the Enbrel Mini cartridge with AutoTouch reusable autoinjector with our Ease of Use Commendation,” said Cindy McDaniel, senior vice president of consumer affairs for the Arthritis Foundation. “This distinction is awarded to products proven to help people who have arthritis and other physical limitations.”