Possible FDA Advisory Committee Meeting for Xeljanz, Olumiant, and Rinvoq Mentioned by Commentators
(Posted by Tom Lamb at Drug Injury Watch)
Drug safety observers are watching the effects a recent FDA alert about Xeljanz-associated heart problems and possible Xeljanz-related cancers has had on other Janus kinase (JAK) inhibitors in the past few weeks. And this has caused some to mention a possible FDA Advisory Committee Meeting for Xeljanz, Olumiant, and Rinvoq, which are all in the JAK inhibitors class of drugs.
As background, in our March 23, 2021, post, "Possible Ramifications of Recent FDA Alert About Xeljanz Heart Problems and Xeljanz-related Cancers", we pointed out this March 18, 2021, BioPharma news report, "AbbVie's approval delay raises further concerns about JAK drugs".
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.
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And from this April 7, 2021, Reuters news report, "U.S. FDA extends review of Pfizer's experimental skin disease drug", we get these observations:
Guggenheim analyst Seamus Fernandez said in a client note that the FDA could convene a panel to review the safety of JAK inhibitors. While these treatments have shown good effectiveness for eczema at higher doses, Fernandez said he was skeptical of the safety profile at those levels....
The FDA earlier this year said that preliminary results from a safety trial showed an increased risk of serious heart problems and cancer with the use of Xeljanz.
In August, the FDA declined to approve Gilead Inc’s experimental rheumatoid arthritis treatment filgotinib, which also belongs to the same class of oral drugs.
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
In the meanwhile, as stated at the conclusion of our February 17, 2021, post, "Xeljanz Has A New Drug Safety Issue, We Just Don't Know How Significant It Is, Yet", we will continue to watch for more data from the Xeljanz safety trial showing an increased risk of serious heart-related problems and cancer associated with Xeljanz, as well as look for any related developments concerning Olumiant and Rinvoq.
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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