THOUSAND OAKS, Calif. - Amgen (NASDAQ:AMGN)'s Otezla (apremilast) has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of moderate to severe plaque psoriasis in children and adolescents aged 6 to 17 years who are candidates for phototherapy or systemic therapy. This marks the first FDA-approved oral medication for this condition in the pediatric population.
The approval was based on the SPROUT study, a Phase 3 trial showing that 33.1% of patients treated with Otezla achieved a significant improvement in their condition, as measured by the static Physician's Global Assessment (sPGA), compared to 10.8% of those on placebo. The treatment is to be administered in 20 or 30 mg doses, twice daily, depending on the patient's weight.
Murdo Gordon, Amgen's executive vice president of Global Commercial Operations, emphasized the importance of this new treatment option for young patients and their caregivers, given the chronic and often uncomfortable nature of plaque psoriasis. Leah M. Howard, JD (NASDAQ:JD), president and CEO of the National Psoriasis Foundation, also expressed support for the new oral treatment option.
The safety profile of Otezla in pediatric patients was consistent with that observed in adults, with the most common side effects being diarrhea, nausea, upper respiratory tract infection, tension headache, and headache.
Amgen has emphasized their commitment to ensuring that appropriate patients have affordable access to Otezla. The company is also recognized for its innovation and has been included in the Dow Jones Industrial Average® and the Nasdaq-100 Index®.
The availability of Otezla for pediatric use expands treatment options for the approximately one-third of psoriasis patients who are under 18 years old at the onset of the disease. The information in this article is based on a press release statement from Amgen.
In other recent news, Amgen's drug candidate, MariTide, has been receiving positive feedback from Key Opinion Leaders (KOLs), indicating that a slower titration approach could address tolerability concerns. TD Cowen maintained a Buy rating on Amgen's shares, setting a price target of $381. The firm's stance reflects their confidence in MariTide's market potential and Amgen's ability to handle the drug's tolerability issues.
In a recent development, Medicare is set to negotiate prices for 10 costly drugs, including Amgen's Enbrel, as part of the Biden administration's Inflation Reduction Act. The move is expected to save the U.S. government $6 billion in the first year. The new prices are scheduled to take effect in 2026, potentially impacting the financial health of the involved companies, including Amgen.
Amgen's shares have also been a subject of varying analyst opinions. While TD Cowen and RBC Capital raised their price targets for Amgen, maintaining positive ratings, Wells Fargo downgraded Amgen's stock to Equal Weight. These differing views highlight the influence of analyst opinions on market perception and could potentially impact the company's future strategies.
InvestingPro Insights
As Amgen (NASDAQ:AMGN) secures FDA approval for Otezla in treating pediatric plaque psoriasis, the company's financial metrics and market performance provide a broader context for investors. Notably, Amgen has demonstrated a commitment to shareholder returns, as evidenced by its impressive track record of raising its dividend for 13 consecutive years, a testament to its financial health and management's confidence in the company's future.
InvestingPro data reveals a robust market capitalization of $176.23 billion, underscoring Amgen's significant presence in the biotechnology industry. The company's P/E ratio stands at 55.95, indicating a high valuation by the market, which may reflect investor confidence in its growth prospects and innovative capabilities. Moreover, Amgen's dividend yield is currently at 2.74%, offering an attractive income stream for investors.
While Amgen is trading at a high earnings multiple, with an adjusted P/E ratio for the last twelve months as of Q2 2024 at 79.66, it's important to recognize that the company is a prominent player in its sector. This high multiple may be attributed to the company's strategic positioning and the potential for future earnings growth, particularly in light of new product approvals like Otezla for pediatric use.
For investors seeking additional insights and analysis, there are 11 more InvestingPro Tips available, which delve deeper into Amgen's financials, stock performance, and industry standing. These tips can be accessed through the dedicated InvestingPro platform at https://www.investing.com/pro/AMGN, offering valuable guidance for those considering an investment in this biotech giant.
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