FDA committee recommends approval of tofacitinib for patients with RA.

NBC Nightly News (5/9, story 5, 1:55, Williams) reported, "New hope for patients who suffer from rheumatoid arthritis." NBC (Besser) added, "For the first time in a decade, an FDA advisory committee today approved a new drug for rheumatoid arthritis...a pill from Pfizer called Tofacitinib, the FDA is expected to give final approval in months." While "biological drugs that target the specific causes of the disease" allows "many but not all patients to live normal lives, thirty to 40% of patients...don't respond to the drugs currently available." And "the FDA panel decided the dangers of the new drug, including an increased risk of lymphoma and elevated cholesterol were outweighed by the benefits."

        The New York Times (5/10, B3, Thomas, Subscription Publication) reports the Food and Drug Administration Arthritis Advisory Committee voted 8-2 to recommend approval of tofacitinib, "a rheumatoid arthritis pill that could offer patients an alternative to the injectable medicines already on the market, but several members expressed concern about safety and urged...rigorous follow-up studies." The members who voted against approval said that their "analysis showed that cancer rates in the study seemed to increase in higher doses of the drug and over time."

        The AP (5/10, Perrone) reports in a story appearing on over 80 news sites, "Federal health advisers said Wednesday that a first-of-a-kind drug from Pfizer appears to be safe and effective for patients with rheumatoid arthritis, though they recommended follow-up studies to gauge the pill's long-term side effects." In its favor, "studies conducted by Pfizer showed patients improved 20 percent or more on a medical questionnaire that measures arthritis pain and symptoms." Also "panelists said Pfizer's pill could be an important option for patients who haven't responded to other drugs or aren't comfortable with injectable medications."

        Bloomberg News (5/10, Armstrong) reports, "The panel also voted 7-2 that the pill was safe, and 10-0 that it was effective." Still, "panel members said they wanted to see more data on the drug's safety profile, and asked that Pfizer conduct follow-up studies once the treatment goes on the market."

        Reuters (5/10, Yukhananov) reports that the oral medication may be less expensive than the current injectable medications.

        Dow Jones Newswires (5/10, Dooren, Subscription Publication) reports that the panel recommended that the medication be given only to patients who have found another drug unhelpful and further suggested that the FDA approve only the lower 5 mg dose rather than the 10 mg dose also proposed by Pfizer.