Health Boards
The FDA have turned down XELJANZ® (tofacitinib citrate) for the treatment of adult patients with moderate to severe chronic plaque psoriasis. The US regulator sent Pfizer a Complete Response Letter stating that it would be unable to approve Xeljanz (tofacitinib) for psoriasis without additional information. It is thought to relate to the safety of the drug, and Pfizer have responded on their website.
Source: pfizer.com
Quote:
Pfizer Inc. announced it has received a Complete Response Letter from the U.S. Food and Drug Administration (FDA) for its supplemental New Drug Application (sNDA) for XELJANZ® (tofacitinib citrate) for the treatment of adult patients with moderate to severe chronic plaque psoriasis. The Agency provided recommendations specific to the moderate to severe chronic plaque psoriasis sNDA. Pfizer will work with the Agency to determine an appropriate path forward to address their comments, including providing additional safety analyses of XELJANZ for the proposed indication.
“Pfizer remains committed to XELJANZ based on the strength of the clinical data for the treatment of psoriasis,” said Kenneth Verburg, PhD, senior vice president and head of global medicines development, Global Innovative Pharma Business. “It is our goal to work closely with the FDA to understand and address their comments about our filing for the use of XELJANZ in patients with chronic plaque psoriasis.”
Source: pfizer.com