Bump in the Road

On October 14, 2015, the US Food and Drug Administration declined to approve tofacitinib citrate, an oral rheumatoid arthritis drug, for the treatment of moderate to severe chronic plaque psoriasis. The FDA communicated its decision to the manufacturer in the form of a complete response letter, which typically outlines concerns and conditions that must be addressed in order to gain FDA approval following initial review of an application.

A recent press release indicated that the manufacturer is committed to pursuing approval of the product based on the strength of the clinical data for its treatment of psoriasis. The FDA generally does not disclose the contents of its complete response letters, but the manufacturer reported it has been asked to provide additional safety analyses of the drug for psoriasis and that it will work closely with the agency to gain the additional approval for treatment of patients with chronic plaque psoriasis.

What’s the Issue?

With the increasing number of psoriasis drugs on the market and in the pipeline, the risk-benefit profile of all drugs needs to be evaluated very carefully. Therefore, safety is the focal issue in all new drug development. Hopefully these issues with the FDA approval of tofacitinib citrate will be worked out so that we may have another oral option for our psoriasis patients. How will this development influence your approach to new therapies?

We want to know your views! Tell us what you think.