New drug for ulcerative colitis! Pfizer xeljanz xrwas approved by FDA as the first daily JAK inhibitor!

December 13, 2019 / Biovalley BIOON / -- Pfizer recently announced that the U.S Food and Drug Administration (FDA) has approved 11 mg and 22 mg of xeljanz XR (tofacitinib) sustained-release tablets for the treatment of adult patients with moderate to severe active ulcerative colitis (UC) who have insufficient or intolerant response to TNF blockers Xeljanz xrwill provide the first and only daily JAK inhibitor for adults with moderate to severe active UC to manage their disease "Ulcerative colitis is a chronic inflammatory disease of the colon, which can seriously affect the quality of life of patients and cause mental burden due to symptoms, flares and complications," said Michael Corbo, chief development officer, inflammation and immunology, Pfizer global product development We are pleased to provide a convenient daily dose selection for patients with moderate to severe active ulcerative colitis and their healthcare providers " Xeljanz / xeljanz xris suitable for patients with moderate to severe active UC with insufficient or intolerant TNF blocker response It is not recommended to use xeljanz / xeljanz xrin combination with biological agents for the treatment of UC or with effective immunosuppressants such as azathioprine and cyclosporine Xeljanz 10mg twice a day or xeljz xr22 mg once a day can be given as induction therapy for eight weeks or up to 16 weeks Subsequently, xeljanz 5mg twice daily or xeljz xr11 mg once daily can be given as maintenance treatment For patients who lose their response during maintenance therapy, consider taking 10 mg xeljanz twice a day or 22 mg xeljanz XR once a day and limit it to the shortest duration, while carefully considering the benefits and risks to individual patients Use the minimum effective dose required to maintain the response Patients with moderate or severe renal function impairment or liver function impairment need to adjust the dosage For dose adjustment, please refer to xeljanz / xeljanz xrfull prescription information: https://labeling.pfizer.com/showlabeling.aspx? Id=959 The active component of xeljanz / xeljanz xris tofacitinib, which is an oral JAK inhibitor It can selectively inhibit JAK kinase and block JAK / STAT pathway, which is a signal transduction pathway stimulated by cytokines in recent years It is involved in many important biological processes such as cell proliferation, differentiation, apoptosis and immune regulation In the United States, xeljanz was approved in 2012, the first JAK inhibitor on the market, taking orally twice a day; xeljanz XR is a sustained-release preparation, approved in 2016, the first JAK inhibitor on the market, taking orally once a day At present, these two drugs have been approved for three indications: (1) treating adult patients with moderate to severe active rheumatoid arthritis (RA); (2) treating adult patients with active psoriatic arthritis (PSA); (3) treating adult patients with moderate to severe ulcerative colitis (UC) At present, Pfizer is still the leader in the field of JAK inhibitors According to the company's third quarter performance report released at the end of October, in the first nine months of this year, xeljanz's sales reached $1.634 billion, an increase of 34% over the same period in 2018, including 25% growth in the U.S market and 69% growth in the international market However, the safety of xeljanz high dose (10mg tablet) has been a constant problem In the first half of this year, US and EU regulators issued safety warnings and restrictions on xeljanz 10mg tablets due to pulmonary embolism and mortality imbalance, which will have a negative impact on xeljanz's business prospects On the other hand, in the JAK inhibitor market, two new drugs that have been launched - Lilly lumiant, Alberto rinvoq, and Gilead's filgotinib, which will be launched in 2020, will bring more competitive pressure to xeljanz In particular, rinvoq and filgotinib have shown high safety in clinical trials Original source: FDA approvals xeljanz ® XR (tofacitinib) extended-release tables for the treatment of ultimate colors