On Tuesday, the U.S. Food and Drug Administration (FDA) approved Johnson & Johnson’s (NYSE:JNJ) Simponi (golimumab) for children with moderately to severely active ulcerative colitis (UC) who weigh at least 15 kg.
The approval is supported by data from the PURSUIT program, which included two multi-center, open-label studies to evaluate the efficacy, safety, and pharmacokinetics of subcutaneously administered Simponi for pediatric ulcerative colitis.
In the Phase 3 PURSUIT 2 study, the primary endpoint of clinical remission at Week 6 was achieved by 32% of patients.
The secondary endpoints of clinical response at Week 6 were achieved by 58% and endoscopic improvement at Week 6 was achieved by 40% of patients receiving Simponi.
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Among patients treated with Simponi who were in clinical remission at Week 6, 57% maintained clinical remission of symptoms at Week 54.
This is the first pediatric approval for Simponi, which is already approved for four indications, including adults living with moderate to severe rheumatoid arthritis (RA), active psoriatic arthritis (PsA), active ankylosing spondylitis (AS), and moderately to severely active ulcerative colitis.
JNJ Price Action: Johnson & Johnson shares were up 0.17% at $189.21 at the time of publication on Wednesday. The stock is trading near its 52-week high of $189.92, according to Benzinga Pro data.
Johnson & Johnson, with a market cap of $455.68 billion, operates in the pharmaceuticals sector, where it has maintained a relatively stable P/E ratio of 20.22, reflecting moderate growth expectations.
The stock is currently near its 52-week high of $189.92, indicating strong investor confidence amid a backdrop of increasing demand for healthcare products globally, particularly in light of ongoing public health challenges.
Additionally, the dividend yield of 2.75% suggests a commitment to returning value to shareholders.
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