During the past couple of weeks, three large companies, AbbVie, Lilly, and Pfizer have recieved requests by the FDA that essentially delay the approval of their atopical dermatitis drugs that function as JAK inhibitors (1).
Pfizer has been developing abrocitinib, an oral drug that is a selective JAK inhibitor and is designed for treatment of sever atopic dermatitis. Their NDA review has been pushed back by 3 months by the FDA. This is raising eyebrows as another drug by Pfizer, tofacitinib (Xeljanz) had many safety questions and severe side effect concerns after FDA review (2). The drug also fuctioned as a JAK inhibitor, but was under review for treatment of different conditions.
Eli Lilly has also recently seen delays with Olumiant, another drug that is a JAK inhibitor, and that has also been in the news due to the molecule being a potential COVID-19 treatment. However, this week, their NDA for the compound as a treatment for dermatitis has also faced a three-month delay (1). This comes right after news broke that AbbVie’s Rinvoq faced a delay in the final decision by the FDA (3).
That tallies three very large companies facing large and costly delays for approval of JAK inhibitors due to mixed concerns of the drug class. Does this mean that the FDA is trying to phase out the drug class? Needless to say, alternative treatments should be explored.
By: Pavle Mihajlovic