Prescription guidance and label change for Xeljanz on UC

MFDS in process of revising indication for Xeljanz, finalized by next month at earliest

FDA and EMA push down treatment line and recommends reserving the drug to high risk patient

Post-marketing interim clinical trial data shows risk in blood clots in lung

The Korean health authority is predicted to narrow down the use of Pfizer’s treatment for patients with ulcerative colitis, Xeljanz (tofacitinib citrate) soon.

 

Ministry of Food and Drug Safety (MFDS) is expected to conclude its decision on pharmaceutical safety and revising related indication of Xeljanz, as discussed in-depth with Pfizer Korea over last year.

 

MFDS could not disclose details of the revised indication, but the ministry would highly likely to follow decisions by the U.S.

 

Food and Drug Administration (FDA) and European Medicines Agency (EMA).

 

In last July, the U.S.

 

FDA has pushed down the treatment line of Xeljanz from first-line treatment for ulcerative colitis to second-line treatment.

 

After negotiating with FDA, the U.S.

 

headquarter of Pfizer has inserted Black Box Warning in its labeling, and changed its indication for treating ulcerative colitis.

 

With the change in the U.S., now Xeljanz is reserved to treat patients with ulcerative colitis, who have failed or do not tolerate conventional therapy, or tumor necrosis factor (TNF) blockers.

 

In last November, EMA has recommended that 10 mg high-dose of Xeljanz should not be prescribed to all patients at high risk of blood clots in lung, including individuals taking hormonal contraceptives or hormone replacement therapy or scheduled to have a major surgery, unless there is no other option.

 

The European authority has recommended patients with high risk of blood clots, who absolutely need high-dose of treatment for ulcerative colitis, should avoid Xeljanz but use other alternative option.

 

After reviewing interim data from ongoing safety clinical trial of Xeljanz and TNF blocker-class Humira and Remicade, the U.S.

 

and European health authorities have made the decisions.

 

According to the interim data, 19 cases of blood clots in the lung out of 3,884 patient-years of patients administered with Xeljanz demonstrated a meaningful difference compared to three cases out of 3,982 patient-years in patients administered with TNF blockers.

 

Xeljanz is indicated to treat patients with rheumatoid arthritis, psoriatic arthritis, and ulcerative colitis.

 

5 mg dose is administered twice-daily for rheumatoid arthritis, and for ulcerative colitis, 10 mg is administered twice-daily for eight weeks and continue the process with either 5 mg or 10 mg of Xeljanz twice-daily depending on treatment response.

 

Ministry of Health, Labour and Welfare of Japan has also added venuous thromboelism as a ‘serious adverse reactions’ on Xeljanz’ label in last August.

 

The ministry recommended medical professionals to consider other alternative when prescribing the drug on patients with high risk of cardiovascular events.