AbbVie Inc.
ABBV
announced that the FDA has approved its JAK inhibitor, Rinvoq (upadacitinib) for a new indication. The drug is now approved for the treatment of adults with active psoriatic arthritis (PsA) who has had an inadequate response or intolerance to one or more tumor necrosis factor (TNF) blockers. This marks the second approved indication for Rinvoq in the United States.
The latest FDA approval was based on data from two pivotal phase III studies – SELECT-PsA 1 and SELECT-PsA 2, which evaluated the safety, efficacy and tolerability of once-daily Rinvoq (15 mg) in patients with PsA.
Data from both the studies showed that treatment with Rinvoq demonstrated efficacy across multiple measures of disease activity in active PsA with a safety profile similar to that seen in rheumatoid arthritis (RA). Treatment with Rinvoq improved joint pain, swelling and stiffness, fatigue, and prevented further joint damage for the given patient population.
Across both studies, patients treated with Rinvoq achieved significantly higher ACR20 responses versus placebo at week 12 — the primary endpoint.
We note that Rinvoq (15 mg) is approved in the United States for treating moderate-to-severe RA in adults when one or more TNF blockers have been used and did not work well or could not be tolerated.
However, AbbVie recently announced an
update
to the prescribing information for Rinvoq for the treatment of adults with moderate-to-severe RA.
The update follows a Drug Safety Communication (DSC) issued in September by the FDA, following its final review of the post-marketing study evaluating
Pfizer
’s
PFE
Xeljanz (tofacitinib) in patients with RA.
The results of this study showed a higher rate of major adverse cardiac events (MACE), malignancy, mortality and thrombosis in Pfizer’s Xeljanz, a JAK versus TNF blockers. The DSC and this label update apply to the class of systemically administered FDA-approved JAKs indicated for the treatment of RA and other inflammatory diseases. Pfizer is also working on expanding the label of Xeljanz.
Consequently, the updated Rinvoq label includes boxed warnings about an increased risk of serious heart-related events, cancer, blood clots, and even death.
Shares of AbbVie have rallied 18.8% so far this year compared with the
industry
’s increase of 16.4%.
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We remind investors that the European Commission had approved Rinvoq for adults (15 mg and 30 mg) and adolescents (15 mg) with moderate-to-severe atopic dermatitis. Rinvoq 15 mg is approved by the European Commission for adults with moderate-to-severe active rheumatoid arthritis in adults with active PsA and adults with active ankylosing spondylitis.
Several late-stage studies on Rinvoq for atopic dermatitis, psoriatic arthritis, axial spondyloarthritis, Crohn’s disease, ulcerative colitis, giant cell arteritis and Takayasu arteritis are currently ongoing.
Rinvoq generated sales of $1.13 billion in the first nine months of 2021. A potential label expansion of the drug will increase the sales potential in the days ahead.
Zacks Rank & Stocks to Consider
AbbVie currently carries a Zacks Rank of #3 (Hold). Some better-ranked stocks in the healthcare sector include
GlaxoSmithKline plc
GSK
and
Endo International plc
ENDP
. While GlaxoSmithKline currently holds a Zacks Rank #2 (Buy), Endo International sports a Zacks Rank #1 (Strong Buy) at present. You can see
the complete list of today’s Zacks #1 Rank stocks here
.
GlaxoSmithKline’s earnings estimates have been revised 8.2% upward for 2021 and 5.5% for 2022 over the past 60 days. The stock has rallied 16.5% year to date.
GlaxoSmithKline’s earnings surpassed estimates in two of the trailing four quarters, missed the same once and matched it once.
Endo International’s earnings estimates have been revised 24% upward for 2021 and 10.3% for 2022 over the past 60 days.
Endo International’s earnings surpassed estimates in each of the trailing four quarters.
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