Johnson & Johnson JNJ announced that it will discontinue the phase III LOTUS study of Stelara (ustekinumab) in Systemic Lupus Erythematosus (SLE) due to lack of efficacy. The decision to halt the study was based on data from a pre-planned interim efficacy analysis.
SLE is an autoimmune disease in which the immune system attacks its own tissues, causing widespread inflammation and tissue damage in the affected organs. However, the company stated that the decision to discontinue the LOTUS study did not impact any other ongoing studies with Stelara or current indications.
Shares of the company have decreased 4.2% year to date compared with the industry’s 2.4% decline.
Stelara is presently marketed for active ulcerative colitis, psoriatic arthritis and moderate-to-severe Crohn's disease for adult patients in both the United States and the EU. The drug is also approved to treat plaque psoriasis in adolescent and adult patients aged 12 years and above.The drug is being studied for axial spondylitis in phase III studies.
Stelara is a top-line driver for J&J. Notably, in the first quarter of 2020, Stelara generated sales of $1.82 billion, reflecting a year-over-year rise of 29.5%, driven primarily by the Crohn's disease indication.
Continuous label expansion of the drug is not only expanding its eligible patient base but also contributing significantly to the company’s top line.
However, the discontinuation of the study will halt the expansion of the drug’s label and not contribute tosales.
GlaxoSmithKline’s GSK Benlysta is a human monoclonal antibody that was approved for the treatment of lupus by the FDA on Mar 9, 2011.
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Zacks Rank &Stocks to Consider
J&J currently carries a Zacks Rank #3 (Hold). A few better-ranked stocks worth considering in the large-cap pharma sector include AstraZeneca Plc AZN and Eli Lilly and Company LLY, both carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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