Pfizer's Xeljanz Set To Lag Lilly's Olumiant In Europe Following Past Rebuffs
Pfizer's Xeljanz (tofacitinib) has finally won a green light from the European Medicines Agency's CHMP for treating rheumatoid arthritis, but its two previous rejections by the panel on safety grounds might curb sales.
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The oral pill, perhaps best known to investors for failing to live up to initial expectations in rheumatoid arthritis, has found its groove – and new opportunities in psoriatic arthritis and ulcerative colitis are on the horizon.
FDA complete response letter seeks additional data on dosing and other safety concerns, delaying potential approval for an NDA that already had been pushed back three months. Interleukin-6 inhibitors sarilumab and sirukumab, now under review at FDA, both could obtain approval before baricitinib.
Pfizer says its former global marketing director emailed and copied hundreds of documents on product launch plans and steps to obtain government approvals before leaving the company in January.