For anyone who thought Pfizer’s RA candidate tofacitinib would sail through its review tomorrow with an FDA advisory committee, documents released ahead of the meeting indicate the devil’s in the details. A briefing hints that the panel could mull over the molecule’s cardiovascular effects and the methodology used to evaluate the drug. Although the cardiovascular impact appears negligible, advisors are almost certain to take a close look at radiographic impact, which Pfizer has used to measure disease progression. The 10mg dose may also get scrutiny due to elevated liver enzymes, said ISI Group analyst Mark Schoenebaum in a webcast on Monday, and the panel may come out solidly against it as a way to prevent over-medication. An added ding: the FDA said the 5mg option was the only one to show a significant change in disease progression. Among other discussion points arising from the briefing documents were malignancy rates, which seemed to rise the longer patients were on the drug, and renal toxicity, which Schoenebaum doesn’t deem a key worry. Nor does the analyst expect a rise in liver enzyme among tofa’ patients taking other RA treatments to be a serious concern. If approved, tofa’, an oral drug, would go up against top-selling RA biologics like Abbott’s Humira and J&J’s Remicade.
Pfizer said Monday that a long-term study of its anti-depressant Pristiq shows that the drug, when compared to placebo, has a lower relapse rate among post-menopausal women with major depressive disorder. The relapse rate among Pristiq users was 14.3%, the firm said, compared with 30.2% among placebo users. Over the long term, subjects who abruptly ended treatment evinced no statistically significant difference in discontinuation symptoms vs. patients who were weaned off of the medication. (Subjects were followed through an eight-week open-label period, a 12-week observation period, and then a six-month period in which they remained on the 50mg dose, were tapered off the drug or were given a placebo.) The FDA approved the drug in 2008, and it came to Pfizer in its 2009 acquisition of Wyeth.
Sanofi has started to shut down a Jackson County, MO, manufacturing plant that the drugmaker had targeted for closure in 2009. The three-stage process will begin June 30 and will continue through December 31, 2014. Spokesman Jack Cox told MM&M that employees have known when their particular jobs are to end since May 2011. Cox said lower product volume is driving the closure and that the work will be shifted to other US plants. The layoffs affect 337 workers.
