Tofacitinib fda orange book approved drug product list. Food and drug administration fda has granted breakthrough therapy designation for the investigational, oncedaily oral jak1selective inhibitor upadacitinib abt494 in adult patients with moderate to severe atopic dermatitis who are candidates for systemic therapy this breakthrough therapy designation is supported by positive phase 2b results. Sep, 2017 a study of tofacitinib in patients with ulcerative colitis in stable remission the safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Australian public assessment report for tofacitinib as citrate. Tofacitinib citrate xeljanz is a drug prescribed to treat rheumatoid arthritis. We have brought new drug application nda 203214 supplement 17 and 208246 supplement 3 for tofacitinib immediate release and. Fda approves boxed warning about increased risk of blood clots and death with higher dose of arthritis and ulcerative colitis medicine tofacitinib xeljanz, xeljanz xr. Auspar xeljanz tofacitinib citrate pfizer australia pty ltd pm20120078833. Laxer, in textbook of pediatric rheumatology seventh edition, 2016. Australian public assessment report for tofacitinib citrate. Tofacitinib can be used as monotherapy for adults who cannot take methotrexate because it is contraindicated or because of intolerance, when the above criteria are met. Supplemental new drug applications for 5 mg tofacitinib taken twice daily and extended release 11 mg tofacitinib taken once.
And chs0214, a proposed etanercept biosimilar, has met its primary endpoint at week 24 in an ongoing 52week study. On february 24, 2016, the us food and drug administration fda approved a new formulation for tofacitinib citrate xeljanz xr. Food and drug administration fda has approved xeljanz xr tofacitinib citrate extendedrelease 11 mg tablets for the oncedaily treatment of moderate to severe rheumatoid arthritis ra in patients who have had an inadequate response or intolerance to methotrexate mtx. The drug is approved in europe and the united states. Aug 30, 20 tofacitinib xeljanz special investigation for rheumatoid arthritis the safety and scientific validity of this study is the responsibility of the study sponsor and investigators. List of approved drug products containing tofacitinib in the fda orange book on. It acts as an inhibitor of janus kinase jak, blocking the subtypes jak1 and jak2. Fda says no to baricitinib for rheumatoid arthritis. Patients treated with tofacitinib 5 mg filmcoated tablets twice daily may be switched to tofacitinib 11 mg prolongedrelease tablets once daily on the day following the. Fda advisory committee meeting snda 203214supplement. Figure 18 of the fda briefing compares the treated patients to placebo patients. Fda approved tofacitinib citrate for the treatment of adult patients in the u.
Fda advisory committee recommends approval of tofacitinib for psa. Prnewswire today the fda is warning about a safety signal that emerged in a required postmarketing trial of the drug xeljanz tofacitinib. Xeljanz rejected by european medicines agency rheumatoid. Fda arthritis advisory committee recommends approval of tofacitinib for adult patients with moderately to severely active rheumatoid arthritis new york, may 09, 2012 business wire. Paul changelian, a scientist in pfizers immune suppression group, was looking for a new way to prevent organ transplant rejection. Side effects, drug interactions, dosing information, pregnancy safety information, and patient warnings and precautions is included. Xeljanz tofacitinib citrate 5 mg tablets for the treatment of psoriatic arthritis advisory committee meeting briefing document page 1 advisory committee briefing materials.
In may, 2012, the fda advisory committee recommended tofacitinib 1 for ra. Aug 22, 2017 fda committee approves tofacitinib for psa on aug. After the initial approval of the drug, the food and drug administration fda required the manufacturer to conduct a postmarketing safety trial comparing two. Tofacitinib cp690,550 ulcerative colitis advisory committee meeting pfizer inc available for public release page 1 fda advisory committee meeting snda 203214supplement 018 briefing. Aug 03, 2017 fda panel says yes to tofacitinib for psa clear efficacy for symptoms, but radiographic progression benefit remains unclear. Tofacitinib cp690,550 ulcerative colitis advisory committee meeting pfizer inc available for public release page 1 fda advisory committee meeting snda 203214supplement 018 briefing document. Fda approval history for xeljanz tofacitinib used to treat rheumatoid arthritis, psoriatic. Tofacitinib distributes equally between red blood cells and plasma. It may be used as monotherapy or in combination with. Xeljanz xr tofacitinib first oncedaily oral jak inhibitor. Continue treatment only if there is a moderate response measured using european league against rheumatism eular criteria at 6 months after starting therapy. Xeljanz xr is provided as 11 mg tofacitinib equivalent to 17.
Tofacitinib is available in 5 mg immediaterelease filmcoated tablets in bottles of 28, 60, and 180. Serious infections leading to hospitalization or death, including tuberculosis and bacterial, invasive fungal, viral, and other opportunistic infections, have occurred. Boxed warning added to tofacitinib prescribing information mpr. Food and drug administration fda approved pfizers xeljanz tofacitinib on dec. Do jak inhibitors increase the risk of venous thromboembolic events. Tofacitinib tofacitinib xeljanz national drug monograph april 2014. A study of tofacitinib in patients with ulcerative colitis. The fda said it approved tofacitinib with a risk evaluation and mitigation strategy rems, which consists of a medication guide advising patients about important safety information and a communication plan to inform health care providers about the serious risks associated with xeljanz.
What is the most important information i should know about tofacitinib xeljanz, xeljanz xr. Clinical trials for tofacitinib the european union clinical trials register allows you to search for protocol and results information on. Tofacitinib citrate is the first oral jak inhibitor approved for chronic use in ulcerative colitis tofacitinib is a small molecule, not a biologic. Themetabolism of tofacitinib is primarily mediated by cyp3a4 with minor contribution from cyp2c19. The us food and drug administration fda has approved tofacitinib citrate extendedrelease xeljanz xr, pfizer inc 11mg tablets for oncedaily treatment of moderate to severe rheumatoid. Xeljanz, xeljanz xr tofacitinib dosing, indications. Tofacitinib xeljanz special investigation for rheumatoid.
Food and drug administration fda voted 101 to recommend the approval of the proposed dose of tofacitinib for treating adults with active psoriatic arthritis psa. In vitro studies indicate that tofacitinib does not significantly inhibit or induce the activity of the major human drugmetabolizing cyps cyp1a2, cyp2b6, cyp2c8, cyp2c9, cyp2c19, cyp2d6, and cyp3a4 at concentrations corresponding to the steady state c max of a 10 mg twice daily dose. Fda briefing document arthritis advisory committee meeting. What should i discuss with my healthcare provider before taking tofacitinib xeljanz, xeljanz xr.
Tofacitinib was extensively studied before approval. See full prescribing information for complete boxed warning. Fda approves oncedaily rheumatoid arthritis oral drug. Pfizer announces fda accepts supplemental new drug.
Aug 03, 2017 the fda arthritis advisory committee voted 101 today for recommending approval of the supplemental new drug application for tofacitinib in the treatment of adult patients with active psoriatic. Fda arthritis advisory committee recommends approval of. Pink, oval, extended release filmcoated tablets with a drilled hole at one end of the tablet band and jki 11 printed on one side of the tablet. Apr 26, 20 figure 18 of the fda briefing compares the treated patients to placebo patients. Tofacitinib in combination with methotrexate mtx is indicated for the treatment of moderate to severe active rheumatoid arthritis ra in adult patients who have responded inadequately to, or who are intolerant to one or more diseasemodifying antirheumatic drugs. Fda is alerting the public that a safety clinical trial found an increased risk of blood clots in the lungs and death when a 10 mg twice daily dose of tofacitinib xeljanz, xeljanz xr was used in patients with rheumatoid arthritis ra. Fda advisory committee meeting, 9 may 2012 nda 203214. Tofacitinib binds predominantly to albuminand does not appear to bind to 1acid glycoprotein. Xeljanz xeljanz xr tofacitinib clinical pharmacology. Potential for xeljanzxeljanz xr to influence the pk of other drugs. Pfizer announces fda approval of xeljanz xr tofacitinib. If a serious infection develops, interrupt xeljanzxeljanz xr until the infection is controlled. Fda advisory committee recommends approval of tofacitinib. Fda panel says yes to tofacitinib for psa medpage today.
Xeljanz xeljanz xr tofacitinib boxed warning pfizer. Australian public assessment report for tofacitinib citrate proprietary product name. Tofacitinib xeljanz special investigation for rheumatoid arthritis the safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Briefing information for the october 17, 2018 meeting of the gastrointestinal drugs advisory committee gidac final agenda for the october 17, 2018 meeting of the gastrointestinal drugs advisory. Fda responds to safety signal reported in required postmarketing.
Aes that occurred in the induction trials cohort 1 and extended induction therapy. Fda briefing document gastrointestinal drug advisory committee. Xeljanz tofacitinib is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate. New small molecule therapies in rheumatoid arthritis. Themetabolism of tofacitinib is primarily mediated. Fourteen cases reported from mainland china suggest that tofacitinib tofa may be effective in patients with refractory adultonset stills disease aosd, further adding to a growing list of potential use of jak inhibition in managing inflammatory, and now autoinflammatory, disease. Fda approval history for xeljanz tofacitinib used to treat rheumatoid arthritis, psoriatic arthritis, ulcerative colitis. Fda approves xeljanz for psoriatic arthritis national. Ra is a chronic autoimmune disease characterized by inflammation and destruction of joints. The fda arthritis advisory committee voted 101 today for recommending approval of the supplemental new drug application for tofacitinib in the treatment of adult patients with active psoriatic.
Va pharmacy benefits management services, medical advisory panel, and visn pharmacist executives. Tofacitinib citrate reference guide for safe and effective use from the american society of healthsystem pharmacists ahfs di. Xeljanz tofacitinib is an inhibitor of the janus kinase jak family of tyrosine kinases. Patient, health professional, pharmacy, rheumatology. Xeljanzxeljanz xr is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate. Mar 02, 2016 tofacitinib has been released from the fdas risk evaluation and mitigation strategy requirement. Upadacitinib receives breakthrough therapy designation for. Baricitinib, sold under the brand name olumiant among others, is a drug for the treatment of rheumatoid arthritis ra in adults whose disease was not well controlled using ra medications called tumor necrosis factor tnf antagonists. Xeljanz tofacitinib, which was approved in 2012 to treat rheumatoid arthritis as an oral alternative to the rising number of injectable biologics, has annual sales of. Food and drug administration fda has approved xeljanz xr tofacitinib citrate extendedrelease 11 mg tablets as a oncedaily treatment of patients with moderate to severe rheumatoid arthritis ra who have not. The us food and drug administration fda has approved tofacitinib citrate extendedrelease xeljanz xr, pfizer inc 11mg tablets for oncedaily treatment of.
Tofacitinib has been released from the fdas risk evaluation and mitigation strategy requirement. Fda holds off on xeljanz approval for psoriasis rheumnow. Side effects, drug interactions, dosing information, pregnancy safety information, and. A study of tofacitinib in patients with ulcerative colitis in. Aftermath of the fda vote on pfizers ra jak inhibitor. Switching between tofacitinib 5 mg filmcoated tablets and tofacitinib 11 mg prolongedrelease tablets. Fda food and drug administration us gfr glomerular filtration rate. Fda approves tofacitinib for rheumatoid arthritis medscape. Taken twice daily in a 5 mg tablet, xeljanz reduces pain and swelling in the joints, and slows the progression of joint damage, according to studies. The fda has approved changes to the prescribing information for tofacitinib to include new warnings, including a boxed warning, regarding an. A study of tofacitinib in patients with ulcerative colitis in stable remission the safety and scientific validity of this study is the responsibility of the study sponsor and investigators. What are the possible side effects of tofacitinib xeljanz, xeljanz xr. Fda clears extendedrelease tofacitinib xeljanz xr for ra.
Rheumatoid arthritis patients 50 years of age and older with at least one cardiovascular cv risk factor treated with xeljanz 10 mg twice a day had a higher rate of allcause mortality, including sudden cv death, compared to those treated with xeljanz 5 mg given twice daily or tnf blockers in a large, ongoing, postmarketing safety study see warnings and precautions 5. The fda said today that tofacitinib was approved ahead of the products prescription drug user fee goal date of november 21, 2012, the date the agency was. Xeljanz tofacitinib citrate 5 mg tablets for the treatment of psoriatic arthritis advisory committee meeting briefing document page 3. Fda advisory committee meeting snda 203214supplement 018. While the effect looks obvious, it was only statistically significant in some groups.
Fda briefing document gastrointestinal drug advisory. Food and drug administration 10903 new hampshire avenue silver spring, md 20993 1888info fda 18884636332 contact fda. Jan 01, 20 a new oral agent, tofacitinib xeljanzpfizer, has been approved by fda to treat adults with moderately to severely active rheumatoid arthritis ra who have had an inadequate response or intolerance to methotrexate. The mean change in mtss represents an approximately 74 and 87% reductions for the 5 and 10 mg tofacitinib doses, respectively, relative to the change for placebo. Compare prices, print coupons and get savings tips for tofacitinib xeljanz and other rheumatoid arthritis drugs at cvs, walgreens, and other pharmacies. Australian public assessment report for tofacitinib as. Listing a study does not mean it has been evaluated by the u. Tofacitinib is an orally active small molecule, immunosuppressant and janus activated kinase 1, 2 and 3 inhibitor developed by pfizer. Pfizer as extendedrelease tablets administered orally once daily.
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