Pfizer Nets World’s First Sign of Atopic Dermatitis for Xeljanz Cibinqo Track Amid FDA Clearance Timeframe
As the FDA delays decisions on several JAK inhibitors due to safety concerns, its British counterpart has decided to give a new drug from Pfizer its first approval worldwide.
Pfizer’s JAK inhibitor Cibinqo, also known as abrocitinib, has obtained UK Medicines and Health Products Regulatory Agency approval to treat moderate to severe atopic dermatitis, the company.
Notably, the nod covers both the 100 mg and 200 mg doses of Cibinqo. After a post-market trial linked to Pfizer’s other JAK inhibitor, Xeljanz, with increased risks of cardiac side effects and cancer, concerns have grown over the approval of JAK drugs, especially at doses high.
Following the nod, Pfizer’s priority is to work with the National Institute for Health and Care Excellence and the Scottish Medicines Consortium to ensure regular access to Cibinqo, said Pfizer’s biopharmaceutical group president Angela Hwang in the communicated.
Pfizer has conducted a family of clinical trials dubbed JADE to support its Cibinqo records. In the first group of trials to read, the drug was shown to outperform placebo in cleansing the skin. In a bigger victory, Pfizer said a few days ago that the phase 3 JADE DARE trial found that 200 mg of Cibinqo, a once-a-day oral tablet, beat Sanofi’s successful injectable drug. and Regeneron, Dupixent, reducing itching and helping patients achieve near-complete skin lightening.
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Pfizer has valued Cibinqo’s maximum sales potential at $ 3 billion, arguing that a large number of patients with atopic dermatitis do not receive a systemic agent. On a conference call with investors last October, Hwang said winning just an 8% share of the systemic atopic dermatitis market would mean $ 3 billion in revenue for Cibinqo at the peak.
But that optimistic outlook looks fragile after the FDA last week slapped new safety warnings and use restrictions on Xeljanz as well as AbbVie’s Rinvoq and Eli Lilly’s Olumiant. The FDA is updating the boxed warnings for drugs to include wording about the risk of serious heart events, cancer, blood clots, and death. In a more damning move, the FDA is limiting approved use of the drugs to patients who have tried but failed with at least one TNF blocker.
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The restrictions are causing problems for Cibinqo because the FDA views safety signals as a class-wide issue, even though the drugs target different members of the Janus kinase (JAK) family of enzymes. While Xeljanz appears to target JAK3, with weaker actions on JAK1 and JAK2, Cibinqo is designed as a specific inhibitor of JAK1, just like Rinvoq. In a note last Wednesday following the FDA announcement, SVB Leerink analyst Geoffrey Porges said he expects Cibinqo to get the same restrictions and labeling language.
After an FDA postponement in April, the agency again pushed back the application of the atopic dermatitis drug to July. The drug has no known new PDUFA data.