FDA expands Xeljanz approval to certain adults with ulcerative colitis

 

The Food and Drug Administration announced May 30 that it has expanded the approval of Xeljanz (tofacitinib) to include adults with moderately to severely active ulcerative colitis.

In two 8-week placebo-controlled trials, 10 mg of Xeljanz given twice daily induced remissions in 17%-18% of patients. In a placebo-controlled trial among the patients who responded by week 8, Xeljanz, at a 5-mg or 10-mg dose given twice daily, was effective in inducing remission by week 52 in 34% and 41% of patients, respectively. Additionally, 35% and 47% of those patients sustained corticosteroid-free remissions when treated with 5-mg and 10-mg doses, respectively.

Researchers noted the most common adverse effects were diarrhea, elevated cholesterol levels, headache, herpes zoster, increased blood creatine phosphokinase, nasopharyngitis, rash and upper respiratory tract infection.

“New treatments are needed for patients with moderately to severely active ulcerative colitis,” said Julie Beitz, MD, director of the Office of Drug Evaluation III in FDA’s Center for Drug Evaluation and Research in a press release. “Today’s approval provides an alternative therapy for a debilitating disease with limited treatment options.”

Xeljanz is the first oral medication approved for chronic use in moderately to severely active UC. The FDA states that other FDA-approved treatments for the chronic treatment of moderately to severely active ulcerative colitis must be administered through an intravenous infusion or subcutaneous injection.

Xeljanz, made by Pfizer Labs, was previously approved in 2012 for rheumatoid arthritis and in 2017 for psoriatic arthritis.

Find the full press release on the FDA’s website.

llaubach@mdedge.com

 

The Food and Drug Administration announced May 30 that it has expanded the approval of Xeljanz (tofacitinib) to include adults with moderately to severely active ulcerative colitis.

In two 8-week placebo-controlled trials, 10 mg of Xeljanz given twice daily induced remissions in 17%-18% of patients. In a placebo-controlled trial among the patients who responded by week 8, Xeljanz, at a 5-mg or 10-mg dose given twice daily, was effective in inducing remission by week 52 in 34% and 41% of patients, respectively. Additionally, 35% and 47% of those patients sustained corticosteroid-free remissions when treated with 5-mg and 10-mg doses, respectively.

Researchers noted the most common adverse effects were diarrhea, elevated cholesterol levels, headache, herpes zoster, increased blood creatine phosphokinase, nasopharyngitis, rash and upper respiratory tract infection.

“New treatments are needed for patients with moderately to severely active ulcerative colitis,” said Julie Beitz, MD, director of the Office of Drug Evaluation III in FDA’s Center for Drug Evaluation and Research in a press release. “Today’s approval provides an alternative therapy for a debilitating disease with limited treatment options.”

Xeljanz is the first oral medication approved for chronic use in moderately to severely active UC. The FDA states that other FDA-approved treatments for the chronic treatment of moderately to severely active ulcerative colitis must be administered through an intravenous infusion or subcutaneous injection.

Xeljanz, made by Pfizer Labs, was previously approved in 2012 for rheumatoid arthritis and in 2017 for psoriatic arthritis.

Find the full press release on the FDA’s website.

llaubach@mdedge.com

 

The Food and Drug Administration announced May 30 that it has expanded the approval of Xeljanz (tofacitinib) to include adults with moderately to severely active ulcerative colitis.

In two 8-week placebo-controlled trials, 10 mg of Xeljanz given twice daily induced remissions in 17%-18% of patients. In a placebo-controlled trial among the patients who responded by week 8, Xeljanz, at a 5-mg or 10-mg dose given twice daily, was effective in inducing remission by week 52 in 34% and 41% of patients, respectively. Additionally, 35% and 47% of those patients sustained corticosteroid-free remissions when treated with 5-mg and 10-mg doses, respectively.

Researchers noted the most common adverse effects were diarrhea, elevated cholesterol levels, headache, herpes zoster, increased blood creatine phosphokinase, nasopharyngitis, rash and upper respiratory tract infection.

“New treatments are needed for patients with moderately to severely active ulcerative colitis,” said Julie Beitz, MD, director of the Office of Drug Evaluation III in FDA’s Center for Drug Evaluation and Research in a press release. “Today’s approval provides an alternative therapy for a debilitating disease with limited treatment options.”

Xeljanz is the first oral medication approved for chronic use in moderately to severely active UC. The FDA states that other FDA-approved treatments for the chronic treatment of moderately to severely active ulcerative colitis must be administered through an intravenous infusion or subcutaneous injection.

Xeljanz, made by Pfizer Labs, was previously approved in 2012 for rheumatoid arthritis and in 2017 for psoriatic arthritis.

Find the full press release on the FDA’s website.

llaubach@mdedge.com