AbbVie ( ABBV Quick Quote ABBV - Free Report) announced that the European Commission (EC) has granted approval to its JAK inhibitor drug, Rinvoq (upadacitinib) for the treatment of both adults and adolescents with moderate-to-severe atopic dermatitis (AD), also called eczema.
The recommended doses are 15 mg or 30 mg once daily for adults and 15 mg once daily for adolescents (12 to 17 years of age) and adults aged 65 and above
The approval is based on data from phase III studies in AD evaluating Rinvoq, both as a monotherapy and in combination with topical corticosteroids. In the studies, Rinvoq met all primary and secondary endpoints. The drug showed rapid and significant improvement in skin clearance and itch reduction compared to placebo.
Rinvoq is presently approved for treating moderate-to-severe rheumatoid arthritis, ankylosing spondylitis & psoriatic arthritis in Europe. The approval for the AD indication marks the fourth EC-approved indication for the JAK inhibitor drug.
AbbVie’s stock has risen 11.7% this year so far compared with an increase of 19% for the
industry. Image Source: Zacks Investment Research
However, in the United States, Rinvoq is only approved to treat the RA indication. This is because the FDA has delayed its decision on the supplemental biologics license application (sBLA) for Rinvoq in AD as well as for two other indications, active psoriatic arthritis and active ankylosing spondylitis in adults. The FDA cited the ongoing review of
Pfizer's ( PFE Quick Quote PFE - Free Report) post-marketing study, ORAL Surveillance, evaluating its marketed JAK inhibitor drug, Xeljanz (tofacitinib) in patients with rheumatoid arthritis (RA) as the reason for the delay. Though management expects a decision on Rinvoq sBLAs to come in the next few months, there is high uncertainty about the outcome.
In fact, the FDA has delayed decision on regulatory filings related to several JAK inhibitor drugs due to the same reason. The FDA delayed the decision on the new drug application (NDA) of Pfizer’s JAK inhibitor candidate, abrocitinib for moderate-to-severe AD. The FDA was expected to give its decision on the NDA in the third quarter of 2021. The FDA also delayed the decision on Pfizer’s sNDA seeking approval of Xeljanz for active ankylosing spondylitis. The FDA has also delayed the decision on the
Lilly ( LLY Quick Quote LLY - Free Report) / Incyte ( INCY Quick Quote INCY - Free Report) sNDA, seeking approval of JAK inhibitor drug, Olumiant (baricitinib) for AD indication.
The FDA has cited its ongoing review of Pfizer’s post-marketing study, ORAL Surveillance, on Xeljanz, as discussed above, as the reason for all the above delays.
The extension of review periods for sNDAs and other negative updates for JAK inhibitor drugs have raised concerns regarding safety issues of this class of drugs. JAK inhibitors work by blocking a particular signal of a body’s immune response, cytokines, instead of suppressing the immune system as done by DMARDs. However, this class of drugs come with their share of side effects including risk of serious infections, malignancies and thrombosis. Some of these side effects are mentioned as boxed warnings in labels of these JAK inhibitor drugs.
Rinvoq is a key new drug in AbbVie’s portfolio, which, along with another new drug Skyrizi is gradually lowering AbbVie’s dependence on its main immunology medicine, Humira. AbbVie was expecting that with many new indications expected to be approved in the next couple of years, sales of these drugs could be higher and have the potential to replace Humira when generics are launched in 2023. AbbVie expects combined revenues of these two drugs to be more than $15 billion by 2025. However, with the delay in FDA decision on Rinvoq sNDAs and uncertain environment for JAK inhibitor drugs, AbbVie might not be able to meet its sales target for the drug. However, the frequent label expansion approvals in Europe are providing a ray of hope. Rinvoq generated sales of $681 million in the first half of 2021. Rinvoq is also being reviewed in late-stage studies for Crohn’s disease, ulcerative colitis and giant cell arteritis.
AbbVie currently has a Zacks Rank #3 (Hold). You can see
. the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here