U.S. FDA extends review period of Pfizer’s abrocitinib by three months

	The clinical tests of Pfizer’s drug included adolescents as well as adults with moderate-to-severe atopic dermatitis.
	The inhibitor had showed positive results and high efficacy for treating eczema.


In recent developments, American multinational pharmaceutical organization, Pfizer Inc. has announced that the U.S. FDA (Food & Drug Administration) has extended the review time for its experimental atopic dermatitis drug, abrocitinib by three months. The regulatory body’s potential approval is expected in the third quarter of this year.

For those uninitiated, abrocitinib is an oral drug developed by Pfizer which selectively inhibits JAK (Janus kinase). JAK inhibitors refer to a type of treatment that targets a range of autoimmune diseases. Apparently, this inhibition is known to modulate various cytokines that are involved in the pathophysiology of atopic dermatitis.

It is also worth mentioning that other JAK inhibitors, including Indianapolis headquartered pharmaceutical company, Eli Lilly & Co’s Olumiant and AbbVie Inc’s Rinvoq have also raised safety concerns leading to subsequent regulatory delays.

If sources are to be believed, the clinical tests of Pfizer’s drug included adolescents as well as adults with moderate-to-severe atopic dermatitis. Although the inhibitor showed positive results and high efficacy for treating eczema, research analysts have been ambivalent about its administration at high doses.

Pfizer mentioned in a statement that the FDA has also extended the priority review timeframe for Xeljanz, the company’s JAK inhibitor that is currently being studied for the treatment of spondylitis.

Reportedly, the preliminary results from a safety trial indicated an increased risk of cancer and severe heart conditions with the use of Xeljanz.

About Pfizer Inc.

Pfizer Inc. is a New York-headquartered research-based biopharmaceutical organization that primarily focuses on the discovery, manufacture, and development of healthcare products. It is known for many popular brands including Celebrex, Bextra, Diflucan, Robitussin, and Advil among others.

Source Credits –

https://www.reuters.com/article/us-pfizer-fda/u-s-fda-extends-review-of-pfizers-experimental-skin-disease-drug-idUSKBN2BU1GZ