Rheumatoid arthritis drug snags expanded indication

FDA approved an autoinjector to treat rheumatoid arthritis and other diseases.

ACTPen (Genentech) 162 mg/0.9 mL is a single-dose prefilled autoinjector for tocilizumab (Actemra), approved as an additional formulation for adult patients with moderate-to-severe active rheumatoid arthritis (RA) who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs (DMARDs), and for adult patients with giant cell arteritis (GCA).

The ACTPen can be administered by caregivers to patients two years of age and older with active polyarticular juvenile idiopathic arthritis (PJIA) or active systemic juvenile idiopathic arthritis (SJIA).

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It is expected to be available in January.

“When it comes to the administration of medicines, we believe patients should have choices, when possible. With ACTPen for Actemra, we are pleased to offer an additional option to patients who may prefer using the new autoinjector over other formulations,” Sandra Horning, MD, chief medical officer and head of global product development at Genentech, a Roche company, told FormularyWatch.

The market for ACTPen is broad, since approximately 1.5 million people in the United States have RA, and an estimated 228,000 people over aged 50 years in the United States have giant cell arteritis (GCA), according to Genentech. Plus, JIA affects nearly 300,000 Americans, of which PJIA accounts for around 25% and SJIA accounts for around 10%.

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FDA first approved Actemra intravenous infusion formulation for adults with RA in January 2010 and Actemra pre-filled syringe (PFS) formulations for subcutaneous injection (SC) for adults with RA in October 2013.

Then, in May 2017, Actemra SC became the first therapy approved by the FDA for the treatment of adult patients with GCA, a chronic and severe form of vasculitis characterized by inflammation of certain large blood vessels.

Actemra IV was approved by the FDA for patients aged 2 years and older with active SJIA in April 2011 and active PJIA in April 2013, and Actemra SC was approved for these indications earlier this year.

“With more than 9 years of real-world clinical experience, Actemra has been used to treat more than 1 million patients,” Allison Neves, senior manager of external communications at Genentech, told FormularyWatch.

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