Tepezza’s EU Approval Breakthrough: A Game-Changer for Amgen Investors?

Breaking news! The European Medicines Agency’s CHMP just handed Amgen a major win with their positive opinion for Tepezza in treating severe Thyroid Eye Disease (TED). This isn’t just a small step—it’s a giant leap for patients and investors alike. Let’s dig into why this could be a blockbuster moment.

First, the facts: On April 26, 2025, the CHMP recommended approval for Tepezza as the first-ever therapy for moderate-to-severe TED in the EU. This rare autoimmune disease—often linked to Graves’ disease—currently forces patients into risky surgeries or steroid treatments. Tepezza, an IGF-1R inhibitor, offers a non-invasive alternative that targets the root cause of the disease.

Why this matters for investors:
- First-mover advantage: Tepezza is already approved in the U.S., Brazil, and Saudi Arabia. Now, with EU approval imminent (expected within 90 days), Amgen unlocks a market of 450 million people with no competing therapies.
- Orphan drug exclusivity: The EU grants 10 years of market exclusivity for orphan drugs. This locks out competitors until 2035, ensuring steady revenue.
- Strong clinical data: Trials showed Tepezza reduced eye bulging (proptosis) in just 6 weeks, with 83% of patients achieving clinically meaningful improvements in severe cases.

The numbers behind the drug’s potential:
- Patient population: TED affects roughly 15 per 100,000 people globally. In the EU, that translates to ~67,500 patients. Half of these have moderate-to-severe disease, creating a 33,750-patient addressable market.
- Pricing power: Tepezza’s U.S. list price is ~$350,000 per course. Even at a 40% discount in Europe (common for public health systems), that’s still €126 million in annual EU sales—and that’s a conservative estimate.
- Amgen’s stock: The company’s pipeline has been under pressure lately, but Tepezza could reinvigorate growth.

What could go wrong?
- Side effects: The CHMP flagged risks like muscle spasms, hyperglycemia, and hearing loss. However, these are manageable, and the drug’s benefits clearly outweigh the risks in severe cases.
- Pricing pushback: EU governments could negotiate lower prices, but the lack of alternatives gives Amgen leverage.

Bottom line: This is a buy for long-term investors. Tepezza isn’t just a niche drug—it’s a $1 billion+ asset in the making. With no competitors on the horizon and a clear path to approval, Amgen’s stock deserves a closer look.

Final verdict: The CHMP’s nod isn’t just a win for TED patients—it’s a win for Amgen shareholders. This approval cements Tepezza as a cornerstone therapy in a $5+ billion global rare disease market. Investors who act now could reap the rewards as Amgen’s next growth driver hits the clinic and the bottom line.

Action Alert: With the stock still trading below its 2023 highs despite this news, now’s the time to consider a position. But don’t wait too long—the EU’s approval will send ripples across Amgen’s portfolio, and this could be the catalyst the stock needs to shine.