TREMFYA® Receives FDA Approval for Psoriatic Arthritis Treatment
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 2 days ago
0mins
Source: PRnewswire
- FDA Approval Update: Johnson & Johnson announced that TREMFYA® (guselkumab) has received FDA approval to include evidence for inhibiting structural joint damage in adults with active psoriatic arthritis, making it the only IL-23 inhibitor proven to stop further structural damage while providing effective symptom control without new safety signals.
- Clinical Study Results: Supported by 24-week results from the APEX study, TREMFYA® met its primary endpoint of reducing joint symptoms (ACR20) and its major secondary endpoint of inhibiting structural damage progression, demonstrating significant efficacy in biologic-naïve patients and reinforcing its market position.
- Long-term Impact: For patients who switched from the placebo group to TREMFYA® at Week 24, the rate of radiographic progression was reduced by 57% from Week 24 to Week 48, indicating that TREMFYA® can provide significant therapeutic benefits even after initial disease progression, thereby enhancing patients' quality of life.
- Strategic Significance: This label update underscores Johnson & Johnson's commitment to patients with psoriatic arthritis, positioning TREMFYA® as the only IL-23 inhibitor with structural inhibition, which is expected to enhance its competitive edge in the market and meet the long-term joint protection needs of patients.
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Analyst Views on JNJ
Wall Street analysts forecast JNJ stock price to fall
20 Analyst Rating
13 Buy
7 Hold
0 Sell
Moderate Buy
Current: 230.800
Low
190.00
Averages
218.50
High
240.00
Current: 230.800
Low
190.00
Averages
218.50
High
240.00
About JNJ
Johnson & Johnson and its subsidiaries are engaged in the research and development, manufacture, and sale of a range of products in the healthcare field. The Company’s segments include Innovative Medicine and MedTech. The Innovative Medicine segment is focused on various therapeutic areas, including immunology, infectious diseases, neuroscience, oncology, pulmonary hypertension, cardiovascular and metabolism. Its products include REMICADE (infliximab), SIMPONI (golimumab), SIMPONI ARIA (golimumab), STELARA (ustekinumab), TREMFYA (guselkumab), EDURANT (rilpivirine), and INVEGA SUSTENNA/XEPLION (paliperidone palmitate). The MedTech segment includes a portfolio of products used in cardiovascular, orthopedics, surgery, and vision categories. The Cardiovascular portfolio includes electrophysiology products to treat heart rhythm disorders and circulatory restoration products (Shockwave) for the treatment of calcified coronary artery disease (CAD) and peripheral artery disease (PAD).
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
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- Reduced Metastasis Risk: The combination therapy also achieved a 20% reduction in the risk of metastasis or death, extending the time before patients required subsequent therapy to over six years, which greatly enhances long-term patient outcomes.
- Optimizing Treatment Window: The study suggests that early integration of apalutamide may reshape prostate cancer treatment, highlighting the importance of using systemic therapy before and after surgery to improve cure rates and reduce the need for subsequent therapies.
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- Significant Efficacy: Patients treated with apalutamide plus hormone therapy were nine times more likely to have little to no cancer remaining at surgery compared to those receiving hormone therapy alone (8.9% vs. 1.0%), while also reducing the risk of metastasis or death by 20% and extending the time before subsequent therapy was needed to over six years.
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See More
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- Significant Complete Response Rate: Notably, more than one-third of responders achieved complete responses, showcasing the potential curative capability of this treatment regimen, which could provide new therapeutic options and improve patient survival rates.
- Duration of Response: With a median follow-up of 11.8 months, the median duration of response has not yet been reached, suggesting the therapy may offer long-term efficacy, further enhancing its competitive position in the market.
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- Survival Rate Improvement: The treatment combination reduces the risk of developing metastatic disease or dying by 20% and delays the need for additional therapy to over six years, potentially opening new market opportunities for Johnson & Johnson in earlier-stage prostate cancer treatment.
- Market Potential: Given that apalutamide is already approved for certain advanced forms of prostate cancer, positive clinical data could lead to its expansion into earlier-stage patients, potentially establishing a new standard of care for high-risk surgical patients.
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See More
