Pfizer abrocitinib and Xeljanz review delayed by FDA for 3 months

Compilenewborn

On April 7, Pfizer announced that the US FDA has extended the priority review period for the new drug application (NDA) for the oral anti-inflammatory drug abrocitinib.

In addition, the FDA has extended the review period of the supplementary new drug application (sNDA) for the oral anti-inflammatory drug Xeljanz/Xeljanz XR (tofacitinib, tofacitinib) for the treatment of adult patients with active ankylosing spondylitis (AS) by 3 months.

Abrocitinib is an oral small molecule that selectively inhibits Janus kinase 1 (JAK1).

Xeljanz was approved in 2012 and is the first JAK inhibitor on the market.

In the announcement, Pfizer did not disclose the reasons for the FDA's postponement of the NDA and sNDA review period for the above two drugs.

Some analysts pointed out that the postponement of the review of the above-mentioned JAK inhibitors indicates that the FDA will strictly review all drugs in this category.

At present, the drug labels of Olumiant, Xeljanz, and Rinvoq all have a black box warning about the risk of serious infection, blood clots, and cancer.

As the FDA considers taking action on Xeljanz's existing indications, the agency is now also carefully studying pending applications for the entire JAK class of drugs.

Although delaying the review of JAK inhibitors is a setback for the aforementioned companies, it also means that competition between Sanofi and Regeneron's monoclonal anti-inflammatory drug Dupixent is reduced or delayed.

AD is currently Dupixent's largest indication and a "significant growth driver.

Among the three JAK inhibitors that have been postponed for review, Xeljanz has the highest revenue in 2020, reaching $2.

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