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CompilationFan Dongdong
A few days ago, the US FDA stated that it would postpone the decision date of Rinvoq's sNDA application for moderate to severe atopic dermatitis by 3 months.
Not long ago, in mid-March, the approval date of Rinvoq's application for psoriatic arthritis was also delayed by the FDA for 3 months for similar reasons.
For safety reasons, FDA extends the review period for AbbVie RINVOQ's supplementary new drug application
The review period of Rinvoq's two sNDAs has been extended by the FDA one after another.
In the United States and Europe, Rinvoq has been approved as an oral medication for rheumatoid arthritis (RA) once a day.
As the blockbuster Humira is about to lose its exclusive rights to the US market in 2023, AbbVie hopes to fill the revenue gap through Rinvoq.
In the European Union, several Humira biosimilars from Amgen and Bojian have been on the market, greatly reducing Humira's sales.
Reference source: AbbVie's (ABBV) Rinvoq Dermatitis sNDA Review Gets Delayed
Original title: Following the indications for psoriatic arthritis, AbbVie Rinvoq's application for the treatment of moderate to severe atopic dermatitis was postponed by the FDA again
