Will Pharmacovigilance Be Enough To Address Questions About Pfizer’s Tofacitinib?
Definitive data on structural damage measurement can be collected post-market, FDA’s Arthritis Advisory Committee said in voting to support approval. But the panel and FDA were both troubled by uncertainties over the safety profile, especially because the rheumatoid arthritis therapy would be for chronic use.
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With FDA’s early approval of tofacitinib for rheumatoid arthritis – the first JAK inhibitor and, unlike the popular TNF inhibitors, an oral agent – the agency appears to have sided with Pfizer on many issues left up in the air after an advisory committee review.
Settling In To The “New Normal”: Midway Through 2012, Another Banner Year For Drug Approvals Is Within Reach
The forecast for 2012 approvals looks sunny. FDA approved almost as many novel drugs in the first half of 2012 as it did in the first half of its record-breaking 2011 – and the agency has more than twice as many pending NME applications with user fee goals in the next six months as it had last year.
Incyte Corp. hits the trifecta – a first-in-class, first-in-disease and first launch with the Nov. 16 FDA approval of Jakafi (ruxolitinib) for treatment of the progressive bone marrow cancer.