On November 26, 2018, the FDA approved a new autoinjector for individuals with severe rheumatoid arthritis (RA), giant cell arteritis, and polyarticular or systemic juvenile idiopathic arthritis (aged 2 and older). It’s called the ACTPen and it works to administer a single-dose of Actemra.
Actemra has been approved since 2010, but at that time it could only be administered by IV. Then, in 2013, syringes were approved for subcutaneous injection. This new development will give patients yet another option.
Developers understand that no patient is the same, and that’s why creations like this are so incredible. They give patients who too often don’t have a choice, the opportunity to make their own decisions about their healthcare.
Actemra for pediatric patients
Actemra was not given pediatric approval until 2011. Even then, it was not approved for both forms of juvenile idiopathic arthritis until this year. It is still being determined whether pediatric patients will be able to utilize the ACTPen themselves, but until then, caregivers are allowed to administer it for them.
Clinical trials of ACTPen
The first clinical trial of ACTPen compared the bioavailability of Actemra when it was injected with ACTPen verses when it was injected using a syringe. It had 188 participants. It was found that a single injection of Actemra was bioequivalent to the pre-filled syringes of the drug.
The second trial focused on the safety of the ACTPen and whether or not it would be effective for the people actually using it for injection. This study examined 54 patients with rheumatoid arthritis to determine whether or not their caregivers could easily use the ACTPen. Researchers found that those administering the drug were successful using ACTPen.
Both of these studies showed consistency with Actemra’s established safety profile.
Why it’s important
In the world of rare disease research, it’s not just about discovering new treatments and new cures (though both of those are of course desired outcomes). It’s also about developing new innovations which can make life easier for patients and their families. Small improvements to treatment procedures can drastically alter a patient’s quality of life, and this type of progress cannot be overlooked.
This new autoinjector should be available by January of 2019 so stay tuned for future updates!
You can read more about this new approval of ACTPen here.