FDA Delays Decision on AbbVie's Rinvoq sNDA for Moderate-to-Severe Atopic Dermatitis Amid Safety Concerns

Compiled by Fan Dongdong

Recently, the U.S. FDA announced a three-month delay in its decision date for the sNDA application of Rinvoq for moderate-to-severe atopic dermatitis. On Friday, AbbVie stated that the agency expressed concerns regarding the safety of JAK inhibitors and required additional time to review other information submitted by the company. AbbVie expects the FDA to make a ruling on this sNDA application for Rinvoq in early Q3 of this year.

In mid-March, the FDA also delayed the approval date for Rinvoq in psoriatic arthritis by three months for similar reasons. Previously, the FDA had requested additional information from AbbVie regarding the risk-benefit profile of the drug in patients with atopic dermatitis. The company promptly submitted the data, and the regulatory agency subsequently decided to extend the review period for the supplemental New Drug Application (sNDA) to allow for a comprehensive evaluation of the data. [Related Reading:FDA Extends Review Period for AbbVie’s Supplemental New Drug Application for RINVOQ Due to Safety Concerns】

The FDA has consecutively announced extensions to the review timelines for two supplemental New Drug Applications (sNDAs) for Rinvoq. Analysts believe that the agency’s demands for safety data may not be limited to Rinvoq alone but could broadly impact all JAK inhibitors. Recently, the FDA issued a statement regarding another JAK inhibitor, Pfizer’s Xeljanz, warning that the drug may increase patients’ risk of cardiac problems and cancer. Analysts suggest that the FDA’s request for additional safety data for Rinvoq, along with the extended review period, aims to verify whether Rinvoq poses similar safety risks to those associated with Xeljanz.

In the United States and Europe, Rinvoq has been approved as a once-daily oral medication for rheumatoid arthritis (RA). In Europe, the drug is also approved for the treatment of psoriatic arthritis and ankylosing spondylitis. Additionally, the FDA is reviewing the supplemental application for its expanded indication in ankylosing spondylitis. However, the approved labeling includes safety warnings regarding serious infections, thrombosis, and even malignancies.

As the blockbuster drug Humira is set to lose its U.S. market exclusivity in 2023, AbbVie aims to bridge the revenue gap with Rinvoq. AbbVie predicts that Rinvoq’s peak sales will reach approximately $2 billion in 2025. In addition to Rinvoq, AbbVie’s other new drug, Skyrizi, is poised to become a key replacement for its primary revenue-generating drug, Humira.

In the European Union, several Humira biosimilars from companies such as Amgen and Biogen have already been launched, significantly reducing Humira’s sales volume. After 2023, Humira will face a similar predicament in the U.S. market. The positive progress made in ongoing clinical trials for Rinvoq and Skyrizi, coupled with potential label expansions for new indications and continued market penetration for already approved indications, will be key to whether AbbVie can achieve long-term growth in its future performance.

Reference Source: AbbVie's (ABBV) Rinvoq Dermatitis sNDA Review Gets Delayed

Original Title: Following the Psoriatic Arthritis Indication, AbbVie’s Rinvoq Application for Moderate-to-Severe Atopic Dermatitis Delayed Again by FDA