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AbbVie Rinvoq's application for treatment of PsA and AS has been postponed for the second time

 Last Update: 2021-08-10
 Source: Internet
 Author: User

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Pfizer Xeljanz’s previous safety issues have caused JAK inhibitor drugs to be subject to more and more stringent scrutiny by the U.

According to the latest news, the FDA will not be able to make a decision to approve Rinvoq's application for treatment of psoriatic arthritis (PsA) and ankylosing spondylitis (AS) in June

According to AbbVie, when it made the decision to postpone Rinvoq, the FDA said it was still reviewing Pfizer's data

Pfizer's JAK inhibitor Xeljanz, in a post-marketing study for patients with rheumatoid arthritis, found dangerous cardiac side effects and additional risks of cancer, which caused the FDA to raise safety concerns about JAK inhibitor drugs

In addition, the European Medicines Agency's Drug Safety Risk Assessment Committee also issued a safety warning to restrict the prescription of Pfizer's oral JAK inhibitor Xeljanz.

Rinvoq occurs approximately 0.

So far, the FDA has postponed multiple decisions to expand the indications for the drug

Earlier this month, the FDA postponed the approval decision date of Jakafi for the treatment of steroid-refractory chronic graft-versus-host disease (GVHD) by 3 months.

Reference source: AbbVie's big Rinvoq ambitions—and the larger JAK class—face even more uncertainty with latest FDA delays

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