Drug Approvals

AbbVie’s Humira follow-up gets FDA nod

Aug 19, 2019

A potential new blockbuster from AbbVie has gotten the go-ahead from the FDA.

The drug, Rinvoq, belongs to a class of JAK inhibitors that treat rheumatoid arthritis by blocking inflammation-triggering enzymes.

The approval is a major win for AbbVie, which has been looking at ways to generate new revenue as its best-selling drug, Humira, gets ready to face generics competition in the U.S. in 2023.  

But the approval also comes with a black box warning — the FDA’s strictest — alerting patients to the potential serious side effects including infection and lymphoma. The agency also released a general warning about JAK inhibitors after data from a trial showed that Pfizer’s Xeljanz could increase the risk of deadly blood clots at higher doses.

Despite the warnings, analysts have predicted that sales for Rinvoq could pass the $1 billion mark within five years.

Read the full Reuters report.

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