Pfizer Korea said it won approval for Xeljanz Tab. 10mg (tofacitinib citrate) as a treatment for ulcerative colitis on Monday.
|Pfizer’s rheumatoid arthritis drug Xeljanz 5mg|
The drugmaker released the drug as the first oral therapy for rheumatoid arthritis in Korea in 2015.
Xeljanz drew attention as the first oral drug in the rheumatoid arthritis treatment market, which was led by injections such as Humira, Remicade, and Enbrel.
The tablet treats moderate to severe active rheumatoid arthritis in adults who do not respond adequately to methotrexate (MTX) or who do not have drug tolerability.
The company obtained the nod for the tablet in 10mg dosage to treat ulcerative colitis.
It can treat those who do not respond well to conventional treatments or biological agents, including corticosteroids, azathioprine, and 6-mercaptopurine (6-MP). It can also treat moderately to severely active ulcerative colitis in adults who have lost drug response or who do not have drug tolerability.
Three clinical studies to confirm the efficacy of ulcerative colitis have shown that symptoms of patients treated with Xeljanz 10gm improved compared to placebo. The outcomes proved that the drug was effective as a second-line treatment.
After administering Xeljanz 5mg or 10mg twice a day to 593 patients who responded clinically to the 10mg dosage, the group treated with 5mg had 34.3 percent remission rate at the 52nd week while the other with 10 mg had 40.6 percent remission rate.
In October, Pfizer Korea obtained the green light for Xeljanz 5mg to treat moderately to severely active ulcerative colitis in adults and active psoriatic arthritis in adults, too. The company said it has completed all the necessary preparations for ulcerative colitis treatment and the maintenance therapy.
In ulcerative colitis and psoriatic arthritis, patients find it more convenient to take the oral medication than to get injections such as Humira, Remicade, and Enbrel.
Prescriptions of Xeljanz for rheumatoid arthritis are growing. Xeljanz sold 3.98 billion won ($3.57 million) in the first half, significantly expanding about 2.3 times compared to 1.69 billion won a year earlier.
In the use of Xeljanz for ulcerative colitis, patients are advised to take 10mg twice a day for eight weeks. After that, they are recommended to take 5mg or 10 mg twice daily depending on the response.
Such recommendation signals that prescriptions of Xeljanz will keep increasing, observers said.