Header Ads

header ad

請記得這一天!-- 類風濕關節炎(RA)治療進入小分子標靶療法時代


路透社(2012/11/6): 美國食品藥物管理局FDA(星期二)宣布,它已批准輝瑞公司的Xeljanz(tofacitinib) 治療標準治療甲氨蝶呤藥物(MTX)無效之類風濕關節炎(RA)。


FDA Approves Novel Drug For MTX-Resistant RA.
Reuters (11/6, Pierson) reports that the Food and Drug Administration on Tuesday announced it has approved Pfizer's rheumatoid arthritis (RA) treatment, Xeljanz (tofacitinib), for adults with moderate-to-severe RA who either have responded inadequately, or are intolerant to, standard methotrexate-based drugs.
        Bloomberg News (11/7, Armstrong) notes the FDA's Division of Pulmonary, Allergy, and Rheumatology Products Director Dr. Badrul Chowdhury lauded Xeljanz as a "new treatment option for adults suffering from the debilitating disease of RA who have had a poor response to methotrexate." Bloomberg News adds that Pfizer spokesperson Victoria Davis said that although a 30-day supply of the 5-mg, twice-daily dose Xeljanz "will cost $2,055" at wholesale, the price is "less than" the cost for competitors' RA drugs already on the market.
        According to Dow Jones Newswire (11/7, Stynes), Pfizer said it would provide eligible RA patients with monetary assistance to cover their out-of-pocket expenses for the drug. However, Dow Jones points out that in its statement announcing the approval, the FDA noted that according to data from the Centers for Disease Control and Prevention, approximately 1.5 million Americans suffer from RA.
        The AP (11/7) notes that Xeljanz is the first RA therapy from a "new class of pain medications called JAK inhibitors," nearly two weeks earlier "than expected."
        MedPage Today (11/7, Walsh) notes that the agency's approval was based primarily on the results of "two large studies published recently" in the New England Journal of Medicine, which found that "51.5% to 65.7%" of RA patients who were administered Xeljanz "met the American College of Rheumatology criteria of 20% improvement endpoint compared with 26.7% to 28.3% of those given placebo."
        WebMD (11/7, DeNoon) adds that the FDA is requiring Xeljanz to carry a boxed warning, explaining that because the oral drug "inhibits immune responses," it may increase the risk for "serious infections, cancers, and lymphoma." In addition, prescriptions for Xeljanz will include a "medication guide carrying important safety information." The most "common side effects" noted during the clinical trials included "upper respiratory tract infections, headache, diarrhea, and inflammation of the nasal passage and the upper part of the throat." Meanwhile, Pfizer said it is also exploring the use of Xeljanz as a "treatment for other autoimmune diseases such as psoriasis."