AbbVie (ABBV) Files for Rinvoq in Atopic Dermatitis in US & EU

AbbVie Inc. ABBV announced that it has submitted regulatory applications both to the FDA and the European Medicines Agency (EMA), seeking approval for its promising JAK inhibitor, Rinvoq (upadacitinib), for a new indication. The company is seeking approval for once-daily Rinvoq to treat adult patients (15 mg and 30 mg) and adolescents (15 mg) with moderate-to-severe atopic dermatitis or eczema.

Rinvoq was approved by the FDA in August 2019 and the EMA in December last year for treating moderate-to-severe rheumatoid arthritis (RA).

The regulatory filings for atopic dermatitis were based on data from three phase III studies. Data from the studies showed that treatment with Rinvoq led to significant improvement in skin clearance and reduction in itch in adults and adolescents versus placebo, underlining the safety profile of the drug in atopic dermatitis.

Importantly, Rinvoq met the co-primary and all secondary endpoints in all three studies.

Shares of AbbVie have lost 4.8% so far this year compared with the industry’s decline of 1.2%.

We note that, apart from atopic dermatitis, Rinvoq is being evaluated in several studies for other indications. The drug is also being studied for Crohn’s disease, ulcerative colitis, active ankylosing spondylitis and giant cell arteritis.

Meanwhile, regulatory applications seeking approval for Rinvoq to treat adult patients with active ankylosing spondylitis are already under review in the United States and Europe. In June 2020, the company also submitted regulatory applications both to the FDA and the EMA for the medicine to treat adult patients with active psoriatic arthritis.

Notably, the early uptake trends of Rinvoq have been encouraging so far. The drug generated sales of $235 million in the first six months of 2020. AbbVie expects Rinvoq’s global revenues to be approximately $600 million for the current year. A further label expansion will significantly boost Rinvoq’s sales in the days ahead.

Rinvoq along with another immunology drug, Skyrizi (risankizumab), might be the catalyst for AbbVie’s growth in the long run and could offset the potential decline in Humira’s sales following the launch of its biosimilars in the United States, scheduled for 2023. Meanwhile, in the EU, several biosimilars of Humira have been already unveiled by the likes of Amgen AMGN, Biogen BIIB and NovartisNVS generic subsidiary, Sandoz, which has already hurt international sales of Humira.

Zacks Rank

AbbVie currently has a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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