After nine years on the market and winning 11 FDA approvals, Johnson & Johnson and AbbVie’s Imbruvica has gained its first pediatric nod.
This one is for chronic graft-versus-host disease (cGVHD) and gives children ages 1 to 11 their first treatment option for the life-threatening disorder. The FDA first signed off on Imbruvica’s use for those 12 and older with cGVHD in 2017.
The nods are for second-line use after the failure of one or more lines of treatment—such as corticosteroids.
The condition can occur after a stem cell or bone marrow transplant when donor cells attack the recipient’s body. Among children who receive such transplants, 52% to 67% develop cGVHD, J&J said. Among other symptoms, the disorder can cause lung damage, liver inflammation and development of scar tissue in the skin and joints.
Helping the companies gain the pediatric nod was a new oral suspension formulation of the drug, which allows it to be dissolved and administered in a drink. The new formulation helps children who have trouble swallowing capsules or tablets, Paul Carpenter, M.D., the lead investigator of the Imagine trial, said in a statement.
In the phase 1/2 study of 47 children between the ages of 1 and 19, the overall response rate (complete or partial response) was 60%.
After Imbruvica's first FDA approval in 2013 for mantle cell lymphoma, many other blood cancer nods followed. In 2017, when the FDA blessed Imbruvica for cHVGD, the drug became the first approved for the condition.
In 2019, Incyte gained a nod for Jakafi to treat acute GVHD, which occurs with 100 days of transplant. Then last September, Jakafi won an approval for use against cGVHD.
Also a year ago, the FDA endorsed Kadmon’s Rezurock to treat cGVHD. Two months later, Sanofi swooped in with a $1.9 billion purchase of the New York City biotech.
Nine months ago, the FDA sanctioned Bristol Myers Squibb’s aging rheumatoid arthritis drug Orencia for cGVHD. That green light—the first of its kind as a preventative for cGVHD—covered patients age 2 and older.
Imbruvica was developed by Pharmacyclics and J&J. Some questioned AbbVie in 2015 when it bought up Pharmacyclics for $21 billion, but the move has paid dividends. Last year, Imbruvica ranked No. 7 in worldwide drug sales, raking in $9.8 billion.
More good news came last year for AbbVie as a key win in a patent infringement case likely paves the way for the company to retain exclusivity until 2032.