Opzelura Eczema Cream Investigation Announced Over Texture Problems
Following several complaints, Incyte has launched an investigation into reports of problems with several batches of its eczema cream, Opzelura, after determining the active ingredient was not properly dissolving, and amid concerns over the safety of the entire class of medications.
In a corporate statement (PDF) issued on November 2, Incyte announced that it was suspending the distribution of several batches of Opzelura and recalled several tubes, but only for testing purposes. The investigation and recall came after at least three complaints from consumers that the texture felt unusual.
Opzelura is a cream formulation of Jakafi, which belongs to the same class of medications as Xeljanz, which are known as Janus Kinase inhibitors, or JAK inhibitors, and in pill form is approved for the treatment of myelofibrosis; a bone marrow disease. Opzelura is used as a topical cream for eczema.
According to Incyte, which announced the issue during its Q3 2021 earnings call, the texture problem appears to be related to a small amount of the active ingredient not being completely dissolved, which left some tubes of the cream with a gritty texture. However, Incyte informed the FDA that it is conducting “a thorough root cause analysis across all batches to ensure continued product quality and supply.”
Incyte indicates early testing of both the 5 gram and 60 gram batches affected by the problem have not shown a safety or efficacy issue. The announcement did not give details on specific affected batches or lot numbers affected by the problem.
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The announcement comes at a time when JAK Inhibitors like Xeljanz and Jakafi are under intense scrutiny by federal regulators and the medical community.
In February 2021, the FDA issued a safety communication about the potential Xeljanz cancer and heart risks, indicating data from a recently completed post-marketing study found users may be more likely to be diagnosed with cancer or experience major cardiovascular events.
Since then, the FDA has delayed a number of requests for approval involving JAK inhibitors, including both expanded use of Jakafi and Xeljanz, and indications for newer medications from the same class, including Rinvoq and Olumiant.
In June, Abbvie announced expanded approval for Rinvoq was being held up due to similar problems. Before that, in April, Pfizer announced the review for its new oral JAK inhibitor, abrocitinib, had been extended by three months due to the same concerns.
In July, media reports indicated Lilly and Incyte also announced the FDA delayed approval of Olumiant; a rheumatoid arthritis drug seeking expanded approval as an Eczema treatment. It has already been approved to treat the skin condition in 40 countries.
The study behind the FDA’s Xeljanz concerns was initially launched in January 2012, and given the long latency period for many cancers, many users now face concerns they require on-going medical monitoring to detect and diagnose cases in the future.
Former users are now contacting lawyers who are investigating Xeljanz lawsuits and class action claims, to seek additional information which has not been disclosed and compensation for treatments they may now require.