TITUSVILLE, N.J. – Johnson & Johnson (NYSE: JNJ) has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for SPRAVATO® (esketamine) nasal spray to be approved as a standalone treatment for adults with treatment-resistant depression (TRD). This request, announced today, is based on Phase 4 trial results that indicate rapid and sustained symptom improvement.
The company's submission is backed by a decade of research and over five years of real-world usage, which Johnson & Johnson claims supports the safety and effectiveness of SPRAVATO®. The Phase 4 TRD4005 study, a randomized, double-blind, multicenter, placebo-controlled trial, demonstrated a quick change in depression severity within 24 hours after the first dose, maintaining this effect for at least four weeks.
The safety profile observed was consistent with prior data when used in combination with oral antidepressants, without new safety concerns.
Currently, SPRAVATO® is FDA-approved as an adjunctive therapy with an oral antidepressant for adults with TRD and those with major depressive disorder (MDD) who have acute suicidal ideation or behavior.
With approvals in 77 countries and administration to over 100,000 people globally, SPRAVATO® has a substantial user base.
The company's neuroscience head, Bill Martin, PhD, emphasized the need for effective monotherapy options for patients with TRD, who often cycle through ineffective treatments. The company aims to alleviate the significant burden that such conditions impose on patients and their families.
SPRAVATO® is not without serious side effects, including sedation, dissociation, and respiratory depression, and is subject to a Risk Evaluation and Mitigation Strategy (REMS) due to its potential for abuse and misuse. It is also not indicated for pain prevention or relief, nor is it approved for pediatric use.
Johnson & Johnson's pursuit of sNDA approval for SPRAVATO® as a monotherapy reflects its ongoing commitment to addressing complex health challenges. However, the company cautions that the forward-looking statements in the press release are subject to uncertainties inherent in the product development process.
The information in this article is based on a press release statement from Johnson & Johnson.
In other recent news, Johnson & Johnson (J&J) disclosed a strong performance for the second quarter of 2024. The global healthcare leader saw worldwide sales increase by 6.6% to reach $22.4 billion, with a more pronounced growth of 7.8% in the US market.
The company's net earnings for the quarter were reported at $4.7 billion, with a diluted earnings per share of $1.93. The Innovative Medicine and MedTech segments were key growth drivers, with the former seeing a 7.8% increase in sales and the latter expanding by 4.4%.
On the future outlook, J&J projects a 5% growth in 2024, anticipating around $88.2 billion in sales and an operational EPS growth of 8.2%. The MedTech segment is expected to grow around 6% for the full year, although the Innovative Medicine segment may see lower growth due to competition from biosimilars.
Despite the potential decline in the adjusted pretax operating margin, the company remains confident in maintaining its growth guidance and delivering long-term value.
InvestingPro Insights
As Johnson & Johnson (NYSE: JNJ) seeks to expand the use of SPRAVATO® with its new FDA submission, the company's financial health remains a critical factor for investors monitoring the potential impact of this development. According to the latest metrics from InvestingPro, Johnson & Johnson's market capitalization stands robust at $372.29 billion. The company's P/E ratio, a key indicator of market expectations of growth and profitability, is currently attractive at 9.92, which, when compared to the adjusted P/E ratio for the last twelve months as of Q2 2024 of 19.65, suggests a potentially undervalued stock in the near-term earnings perspective.
Investors are also drawn to Johnson & Johnson's strong track record of dividend reliability. The company has not only raised its dividend for 53 consecutive years but has also maintained dividend payments for 54 consecutive years, as highlighted by InvestingPro Tips. This consistency reflects a commitment to shareholder returns, which is further supported by a dividend yield of 3.21% as of the most recent data.
While the company's revenue has seen a decline of 11.02% over the last twelve months as of Q2 2024, Johnson & Johnson's gross profit margin remains high at 69.29%, indicating the company's ability to maintain profitability despite revenue fluctuations. This financial stability, coupled with a strong presence as a prominent player in the Pharmaceuticals industry, is essential for investors considering the potential long-term benefits of the company's strategic moves, such as the expansion of SPRAVATO®'s indications.
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