Incyte investigates API issue with newly-approved eczema cream

Nov. 3, 2021

Just months after getting the FDA nod for its topical JAK inhibitor to treat a common type of eczema, Incyte is already dealing with a manufacturing snag.

During a Q3 earnings call, the Delaware-based biopharma noted having received three product complaints related to Opzelura's texture. Incyte followed up with a press release, stating that the company has informed the FDA and is currently investigating the complaints and conducting a thorough root cause analysis across all batches.

After testing from the batches in question,"analytical tests revealed the texture issue is related to a very small quantity of active product ingredient not being completely dissolved, which has, on occasion, produced a slight gritty texture." Incyte says it will suspend its Opzelura sample program, but there is not product recall. 

Approved back in September with a black box warning, Opzelura, is a novel cream formulation of lncyte's selective JAK1/ JAK2 inhibitor ruxolitinib and the first and only topical JAK inhibitor approved for use in the U.S> for the topical short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis.

Prior to that, the FDA had extended the review period for Opzelura, as it did with all JAK inhibitors, following Pfizer's release of data on a postmarketing study of cardiovascular safety of its JAK inhibitor Xeljanz. The trial found that the use of JAK inhibitors appears to be associated with major cardiovascular adverse events and malignancies. 

Thus, Opzelura's approval came with the requirement to conduct a postmarketing study and set up a patient registry to monitor whether the topical JAK inhibitor has adverse effects on mothers, fetuses and infants. The company said the recent texture issues do not appear to affect the safety or efficacy of the product.

*updated 11/5/21 to reflect that there is no recall on sample-sized tubes of Opzelura, as previously stated