It's a banner day for Pfizer ($PFE): The drugmaker's new rheumatoid arthritis drug tofacitinib, one of its leading hopes for sales growth, finally won its approval from the FDA.
The FDA has handed Pfizer an approval for its oral rheumatoid arthritis drug tofacitinib, which will hit the market soon as Xeljanz. The news will be cheered at Pfizer, which counted the RA drug as one of its most critical late-stage programs, offering a key sign that its R&D program is back on track after years of pratfalls and disasters.
Pfizer put out word this morning that the FDA has opted to delay its application for tofacitinib for three months as it works through some additional analyses the Big Pharma has offered to support its NDA for the rheumatoid arthritis treatment.
The next 5 or 6 weeks look big for potential approvals of new drugs.
At high doses, the oral treatment performed significantly better than a placebo in treating ulcerative colitis in a mid-stage study, offering the prospect of building a major anti-inflammatory franchise.
Pfizer has posted a fresh set of upbeat data on its top blockbuster prospect tofacitinib that will go a long way to easing the sting of its recent bapineuzumab debacle. At high doses, the oral treatment performed significantly better than a placebo in treating ulcerative colitis in a mid-stage study, offering the prospect of building a major anti-inflammatory franchise.
With Pfizer's animal-health unit now being spun out after a major retooling that has included deep cuts on the R&D side of the business, the big question now is whether Pfizer has a sensible research strategy in place as it concentrates its full attention on drug development.
Pfizer's quest to gain an approval for a potential new blockbuster for rheumatoid arthritis has run into a speed bump at the FDA. Following a lopsided expert panel vote in its favor back in May, Pfizer CEO Ian Read told analysts on Tuesday that the agency is looking for some additional data analysis before it can come up with a formal decision on marketing the JAK inhibitor.
You know that old adage: The one with the gold makes the rules? For the latest exhibit, look no further than Pfizer's anticipated rheumatoid arthritis treatment tofacitinib.
The FDA may be a new drug's biggest hurdle, but payers are throwing up more obstacles as high-tech treatments get pricier and healthcare costs keep rising.