Pfizer believes it’s onto a $3 billion winner after the FDA approval of its dermatitis JAK inhibitor Cibinqo in January, but a new report surveying physicians around the world shows prescribing this class of meds may be a tricky sell for reps.
Cibinqo was originally set for an FDA decision last April, but the FDA undertook a classwide safety review of all JAK inhibitors that triggered a series of delays, including for similar meds from AbbVie, Eli Lilly and more.
The JAK safety mess stemmed from concerning findings in a postmarketing study of Pfizer’s original JAK inhibitor, Xeljanz, specifically in rheumatoid arthritis patients who already had cardiovascular risk factors.
Investigators noticed an increased risk of blood clots, major heart-related event death, death and cancer in patients taking the Pfizer drug compared with those on TNF inhibitors.
Although the red flags came from the Xeljanz study, the FDA clearly showed it considers the risks a classwide problem for oral JAK inhibitors by requiring similar updates to AbbVie’s Rinvoq and Eli Lilly’s Olumiant labels.
Pfizer’s approval, delayed or not, was still met with delight from the Big Pharma, which sees $3 billion in peak sales for the drug. But a new report out from GlobalData has cast doubt on how confident doctors around the world are in prescribing JAKs for atopic dermatitis.
According to GlobalData's survey of 120 high-prescribing physicians in seven major markets, prescribing oral and topical JAK meds in eczema “has caused differences in opinion” about how and whether these drugs should be used.
It found the biggest division was seen between the U.S. and Japanese markets, which were “optimistic” about the launch (despite the recent safety updates from the FDA), and the EU and U.K. markets, where doctors noted that JAK inhibitors should only be used in patients with inadequate responses or that see serious side effects when being treated with biologics due to safety concerns.
“It is clear that there are still safety concerns over JAK inhibitors, and this is a key reason for the wavering confidence in the class,” said Ramla Salad, pharma analyst at GlobalData.
GlobalData’s survey revealed that physicians are only “modestly enthusiastic” about the introduction of oral JAK inhibitors, as exemplified by the “mediocre” scores of 3 to 3.3 out of a total of 5.
Salad still believes, however, that with the correct patient selection and monitoring, JAK inhibitors have “the ability to transform the atopic dermatitis space with their fast onset of action.”
“U.S. physicians commented that non-steroidal options are always welcome and that, if approved, topical JAK inhibitors would give patients more choice,” Salad said.