Outside Experts Could Review All JAK Inhibitors Risk/Benefit Profiles as Regards Several Requested New Indications


(Posted by Tom Lamb at Drug Injury Watch)


A few months ago we wrote about a possible FDA Advisory Committee meeting for Xeljanz, Rinvoq, and other Janus kinase (JAK) inhibitors in this April 15, 2021 post, “Xeljanz and Other JAK Inhibitors: Drug Safety Concerns Indicated by Recent FDA Actions“. And recently the FDA delayed its decision for Abbvie’s applications to have Rinvoq approved for the additional indications of psoriatic arthritis and ankylosing spondylitis, apparently due to possible new JAK inhibitors heart side effects and cancer risks issues identified in connection with a Xeljanz safety signal.
From this June 25, 2021, FiercePharma news report, “AbbVie’s big Rinvoq ambitions — and the larger JAK class — face even more uncertainty with latest FDA delays“, we get the following:
The FDA won’t be able to reach decisions for Rinvoq’s applications in psoriatic arthritis and ankylosing spondylitis in June as promised, AbbVie said Friday.
The company didn’t say whether the agency has provided a new decision date. For the psoriatic arthritis indication, the news marks the second deferral.
The problem arises from the FDA’s safety concerns after Pfizer’s fellow JAK inhibitor Xeljanz turned up additional risks for dangerous heart side effects and cancer in a post-marketing study in patients with rheumatoid arthritis.
In postponing Rinvoq, the FDA said it’s still reviewing those Pfizer data, according to AbbVie. In February, the agency alerted patients and doctors of Xeljanz’s safety signal. At that time, it said it would dig into the results and consider what moves to take.
Existing JAK inhibitors, including Rinvoq, already bear warnings of increased risk of blood clots on their U.S. labels. Xeljanz’s cardiovascular red flag obviously made the FDA nervous about it being a class-wide problem for all JAK drugs.
For some additional perspective, we turn to this June 25, 2021, EndpointNews article, “FDA pushes back decisions on AbbVie’s Rinvoq sNDAs to further review a failed Pfizer trial“:
The regulator’s continued evaluation of the Pfizer trial shows those safety concerns have not abated. Pfizer announced in January that ORAL Surveillance, its six-year post-marketing trial for its JAK inhibitor Xeljanz, had failed. Across 4,362 patients, those who received either a low or high dose of Xeljanz experienced more major cardiovascular events — such as stroke and heart attack — than those on Humira or Enbrel. They also had higher rates of cancer, with Pfizer failing to hit non-inferiority on both primary endpoints.
While AbbVie did not provide any more details on what the FDA was looking into with the Pfizer trial, its failure continues to pose difficult questions for a class of drugs that has generated significant efficacy in autoimmune conditions but has faced repeated safety concerns.
We will continue to watch for further developments and indications concerning an FDA Advisory Committee for Xeljanz, Rinvoq, and other JAK inhibitors so that outside experts to review their risk/benefit profiles as regards new indications such as atopic dermatitis.  If this comes to be, we expect that FDA Advisory Committee would be discussing the new JAK inhibitors heart side effects and cancer risks issues which were flagged by means of the earlier Xeljanz safety signal.

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