THOUSAND OAKS, Calif. - The Ministry of Health, Labour and Welfare in Japan has approved TEPEZZA (Teprotumumab) for the treatment of active thyroid eye disease (TED), Amgen (NASDAQ:AMGN) announced today. This marks the first approval of TEPEZZA in Asia and introduces a non-surgical, non-steroidal treatment option for a condition that affects an estimated 25,000 to 35,000 people in Japan.
TED is a rare autoimmune disease that can lead to vision impairment through symptoms such as eye bulging and double vision. Until now, management of TED often involved complex surgeries and high-dose steroids, which could result in further complications. TEPEZZA, which targets the underlying mechanism of the disease, offers an alternative approach to treatment.
The approval was granted based on the results of the OPTIC-J clinical trial, which demonstrated a clinically meaningful improvement in proptosis for 89% of patients treated with TEPEZZA, compared to 11% for placebo at week 24. The safety profile of TEPEZZA was consistent with previous clinical data. A second Phase 3 trial is currently in progress to assess TEPEZZA's efficacy in chronic TED patients with a low clinical activity score.
TEPEZZA's approval was expedited in Japan due to its orphan drug designation, which provided a nine-month regulatory review period. In addition to Japan, TEPEZZA is also approved in the United States, Brazil, and the Kingdom of Saudi Arabia, and is under regulatory review in Europe, Canada, and Australia.
This approval is expected to provide a new avenue of care for patients with active TED in Japan, as it offers a treatment that directly addresses the disease's underlying causes. The information in this article is based on a press release statement from Amgen.
In other recent news, major developments have been reported for biotechnology company, Amgen. The company has released topline clinical data from its Phase 3 studies of rocatinlimab and UPLIZNA®. The studies aim to advance treatments for patients facing inflammation and rare diseases. Additionally, the FDA has approved Amgen's Otezla, the first oral medication for moderate to severe plaque psoriasis in children and adolescents. The approval was based on a Phase 3 trial that showed significant improvement in 33.1% of patients.
In terms of analyst opinions, TD Cowen has maintained a Buy rating on Amgen's shares, reflecting confidence in the company's drug candidate, MariTide. Meanwhile, Oppenheimer maintained a positive stance on Amgen's stock, reiterating an Outperform rating, following promising updates on several of Amgen's oncology programs.
A significant development for the company is that Medicare, as part of the Biden administration's Inflation Reduction Act, is set to negotiate prices for 10 costly drugs, including Amgen's Enbrel. This move is expected to save the U.S. government $6 billion in the first year, potentially impacting the financial health of Amgen. These are among the recent developments for Amgen.
InvestingPro Insights
As Amgen (NASDAQ:AMGN) celebrates the approval of TEPEZZA in Japan, investors and analysts are watching the company's financial health and market performance closely. With a robust market capitalization of $177.73 billion, Amgen stands as a significant player in the biotechnology industry. The company's dedication to innovation is not just reflected in its product pipeline but also in its financial commitments to shareholders, having raised its dividend for 13 consecutive years.
InvestingPro data shows that Amgen is trading at a high earnings multiple with a P/E ratio of 56.83, which further adjusts to 79.48 for the last twelve months as of Q2 2024. This high valuation metric may suggest that investors have high expectations for the company's future earnings growth. Analysts have noted that Amgen's stock generally trades with low price volatility, indicating a level of market stability for the company's shares. However, it's worth noting that 11 analysts have revised their earnings estimates downwards for the upcoming period, which could be a point of consideration for potential investors.
For those interested in further insights, there are additional InvestingPro Tips available on the platform, shedding light on various aspects such as Amgen's trading near its 52-week high and its high Price / Book multiple of 30.06. With a focus on providing value to its shareholders, Amgen has maintained dividend payments for 14 consecutive years, which is reflected in its current dividend yield of 2.68%. To explore more in-depth analysis and tips, including the company's profitability and future predictions by analysts, visit InvestingPro at https://www.investing.com/pro/AMGN.
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