Based on these several recent developments, we expect that there will be an FDA Advisory Committee Meeting for Xeljanz, Olumiant, and Rinvoq in the months to come. The focus of such will likely be these adverse drug events and side effects related to the JAK inhibitors class of drugs:
Heart Attacks
Myocardial Infarction (MI)
Strokes — Ischemic / due to a blood clot
Deep Vein Thrombosis (DVT)
Pulmonary Embolism (PE)
Arterial Thrombosis
Cancers
Death
Last week we saw this April 8, 2021, Endpoints News article with a telling headline, “Series of JAK inhibitor delays may signal an upcoming FDA adcomm”, by Zachary Brennan, from which we get the following insights:
Three-month review delays from the FDA have become the norm in recent days for JAK inhibitors, some of which are seeking label expansions.
But the pushback of these action dates for AbbVie’s Rinvoq, Pfizer’s Xeljanz and abrocitinib, and Eli Lilly’s Olumiant may be a sign that the FDA is preparing to hold an advisory committee of outside experts to review the risk/benefit profiles of JAK inhibitors for atopic dermatitis, according to Leerink analyst Geoffrey Porges. This wouldn’t be the first time this year that the FDA wants to review a series of drugs before an adcomm as the agency is holding such a review later this month for cancer drugs that have previously won accelerated approvals.
We will continue to watch for new information about an increased risk of serious heart-related problems and cancer associated with Xeljanz. And we will look for any related developments concerning the JAK inhibitors class of drugs, such as the possible FDA Advisory Committee Meeting for Xeljanz, Olumiant, and Rinvoq mentioned above.
At the present time, our law firm is investigating possible Xeljanz drug injury lawsuits for people who have been diagnosed with heart-related problems or cancer.
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