UPLIZNA Approved in Europe for gMG Treatment
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 21 hours ago
0mins
Should l Buy AMGN?
Source: PRnewswire
- New Therapy Approval: Amgen announced that UPLIZNA (inebilizumab) has been approved by the European Commission as a new treatment option for adults with gMG who are anti-AChR+ and anti-MuSK+, marking a significant advancement in addressing this rare autoimmune disease.
- Long-Term Control Potential: UPLIZNA demonstrates the potential for long-term disease control through a semi-annual maintenance dose following two initial loading doses, which may reduce patients' reliance on long-term steroids, thereby improving their quality of life.
- Clinical Trial Support: The approval is backed by data from the MINT trial, the largest Phase 3 study for gMG, where 87.4% of UPLIZNA patients successfully reduced their steroid dosage to 5mg or less daily by week 26, showcasing its efficacy.
- Broad Market Prospects: The approval of UPLIZNA not only provides a new treatment option for gMG patients but also positions it to potentially play a significant role in the future market, especially regarding its potential against other autoimmune diseases, further solidifying Amgen's leadership in the biopharmaceutical sector.
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Analyst Views on AMGN
Wall Street analysts forecast AMGN stock price to fall
19 Analyst Rating
11 Buy
7 Hold
1 Sell
Moderate Buy
Current: 366.200
Low
272.00
Averages
345.87
High
425.00
Current: 366.200
Low
272.00
Averages
345.87
High
425.00
About AMGN
Amgen Inc. is a biotechnology company. It discovers, develops, manufactures and delivers medicines for the toughest diseases. It focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve people’s lives. It operates in the human therapeutics segment. Its marketed products portfolio includes EPOGEN (epoetin alfa); Aranesp (darbepoetin alfa); Parsabiv (etelcalcetide); Neulasta (pegfilgrastim); KANJINTI (trastuzumab-anns); Otezla; BLINCYTO (blinatumomab); ACTIMMUNE (interferon gamma-1b); Neulasta (pegfilgrastim); Sensipar/Mimpara (cinacalcet); Prolia (denosumab); ENBREL; QUINSAIR (levofloxacin); Repatha (evolocumab) and others. It markets ENBREL, a tumor necrosis factor blocker, in the United States and Canada. It markets Otezla, a small molecule that inhibits phosphodiesterase 4, in many countries around the world. It markets Repatha, a proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor, in many countries around the world.
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.
UPLIZNA Approved in Europe for Myasthenia Gravis Treatment
- First Therapy Approved: UPLIZNA (inebilizumab) is the first therapy approved by the European Commission for treating generalized myasthenia gravis (gMG) in adults with positive AChR and MuSK antibodies, offering a new long-term control option that is expected to significantly enhance patient quality of life.
- Clinical Trial Success: In the MINT study, 87.4% of patients receiving UPLIZNA successfully reduced their steroid dosage to 5 mg per day or less, demonstrating its effectiveness in minimizing steroid dependency and potentially reducing long-term side effects associated with steroid use.
- Convenient Treatment Regimen: UPLIZNA's administration schedule of twice a year after two initial doses allows for sustained disease control, which may improve patient adherence and treatment outcomes due to its convenience.
- Broad Market Potential: The approval of UPLIZNA not only provides a new treatment option for gMG patients but also positions the drug to capture significant market share, especially as the prevalence of gMG continues to rise globally.
See More
UPLIZNA Approved in Europe for gMG Treatment
- New Therapy Approval: Amgen's UPLIZNA (inebilizumab) has been approved by the European Commission as an adjunct treatment for adults with anti-AChR+ and anti-MuSK+ generalized myasthenia gravis (gMG), marking a significant advancement in treatment options.
- Hope for Patients: The drug offers the potential for long-term disease control through a biannual maintenance dose, which may reduce patients' reliance on long-term steroids, thereby improving their quality of life.
- Clinical Trial Support: The approval is backed by results from the MINT study, which showed that 87.4% of patients reduced their steroid dosage to 5mg or less daily by week 24, demonstrating significant efficacy.
- Broad Market Prospects: The approval of UPLIZNA not only provides a new treatment option for gMG patients but also has the potential to drive Amgen's market share growth in the rare disease sector, further solidifying its leadership in the biopharmaceutical industry.
See More
Amgen's UPLIZNA Approved in Europe for Myasthenia Gravis Treatment
- New Drug Approval: Amgen's UPLIZNA (inebilizumab) has received approval from the European Commission as an adjunct treatment for adults with anti-AChR+ and anti-MuSK+ myasthenia gravis, marking a significant new treatment option for this rare disease.
- Significant Treatment Effects: UPLIZNA offers long-term disease control through a biannual maintenance dose, with studies showing that 87.4% of patients successfully reduced steroid doses to 5 mg or less daily within 26 weeks, greatly improving quality of life.
- Clinical Research Support: The approval of UPLIZNA is backed by positive results from the MINT study, the largest biological study for myasthenia gravis involving 238 patients, validating its safety and efficacy.
- Huge Market Potential: Myasthenia gravis affects approximately 56,000 to 123,000 people in Europe, and the launch of UPLIZNA not only provides patients with a new treatment option but also has the potential to reduce long-term reliance on steroids, enhancing Amgen's competitiveness in the biopharmaceutical market.
See More
European Pharma Companies Look Ahead to 2026
- Patent Cliff Challenge: Pharmaceutical companies are facing an impending patent cliff, with billions in sales at risk, particularly Novartis, which anticipates a $4 billion loss in the first half of 2025, compelling firms to invest heavily in new drug pipelines to offset revenue losses.
- Optimistic Pipeline Outlook: Companies like Novartis and AstraZeneca are emphasizing their robust drug pipelines, with Novartis projecting $59 billion in revenue for 2025 and AstraZeneca aiming for $80 billion by 2030, reflecting confidence in future growth despite current challenges.
- M&A Strategic Focus: As companies seek to replenish revenue through acquisitions, there is a growing emphasis on the Chinese market as a significant source of innovation, with the frequency of deals with Chinese firms increasing markedly over the past decade.
- Pricing Strategy Uncertainty: Although the immediate threat from Trump's Most Favored Nation drug pricing policy has diminished, pharmaceutical companies are still deliberating on how to balance pricing strategies between the U.S. and European markets to ensure market access and profitability for new drugs.
See More
UPLIZNA Approved in Europe for MGg Treatment
- New Treatment Option: UPLIZNA (inebilizumab) has been approved by the European Commission as an adjunct treatment for adults with anti-AChR+ and MuSK+ myasthenia gravis (MGg), offering a biannual maintenance dosage that may reduce long-term steroid use.
- Clinical Trial Support: The approval is backed by data from the MINT study involving 238 MGg patients, where 87.4% of UPLIZNA patients reduced their steroid dosage to 5 mg or less by week 26, demonstrating significant efficacy.
- Market Potential: With an estimated 56,000 to 123,000 individuals affected by MGg in Europe, the approval of UPLIZNA provides a new treatment option for this rare disease, potentially improving patients' quality of life significantly.
- Long-term Efficacy Expectations: By targeting CD19-positive B cells, UPLIZNA offers durable disease control, which may transform the treatment landscape for MGg and lessen patients' reliance on steroids, enhancing overall treatment outcomes.
See More
UPLIZNA Approved in Europe for gMG Treatment
- New Therapy Approval: Amgen announced that UPLIZNA (inebilizumab) has been approved by the European Commission as a new treatment option for adults with gMG who are anti-AChR+ and anti-MuSK+, marking a significant advancement in addressing this rare autoimmune disease.
- Long-Term Control Potential: UPLIZNA demonstrates the potential for long-term disease control through a semi-annual maintenance dose following two initial loading doses, which may reduce patients' reliance on long-term steroids, thereby improving their quality of life.
- Clinical Trial Support: The approval is backed by data from the MINT trial, the largest Phase 3 study for gMG, where 87.4% of UPLIZNA patients successfully reduced their steroid dosage to 5mg or less daily by week 26, showcasing its efficacy.
- Broad Market Prospects: The approval of UPLIZNA not only provides a new treatment option for gMG patients but also positions it to potentially play a significant role in the future market, especially regarding its potential against other autoimmune diseases, further solidifying Amgen's leadership in the biopharmaceutical sector.
See More
UPLIZNA Approved in Europe for Myasthenia Gravis Treatment
- First Therapy Approved: UPLIZNA (inebilizumab) is the first therapy approved by the European Commission for treating generalized myasthenia gravis (gMG) in adults with positive AChR and MuSK antibodies, offering a new long-term control option that is expected to significantly enhance patient quality of life.
- Clinical Trial Success: In the MINT study, 87.4% of patients receiving UPLIZNA successfully reduced their steroid dosage to 5 mg per day or less, demonstrating its effectiveness in minimizing steroid dependency and potentially reducing long-term side effects associated with steroid use.
- Convenient Treatment Regimen: UPLIZNA's administration schedule of twice a year after two initial doses allows for sustained disease control, which may improve patient adherence and treatment outcomes due to its convenience.
- Broad Market Potential: The approval of UPLIZNA not only provides a new treatment option for gMG patients but also positions the drug to capture significant market share, especially as the prevalence of gMG continues to rise globally.
See More
UPLIZNA Approved in Europe for gMG Treatment
- New Therapy Approval: Amgen's UPLIZNA (inebilizumab) has been approved by the European Commission as an adjunct treatment for adults with anti-AChR+ and anti-MuSK+ generalized myasthenia gravis (gMG), marking a significant advancement in treatment options.
- Hope for Patients: The drug offers the potential for long-term disease control through a biannual maintenance dose, which may reduce patients' reliance on long-term steroids, thereby improving their quality of life.
- Clinical Trial Support: The approval is backed by results from the MINT study, which showed that 87.4% of patients reduced their steroid dosage to 5mg or less daily by week 24, demonstrating significant efficacy.
- Broad Market Prospects: The approval of UPLIZNA not only provides a new treatment option for gMG patients but also has the potential to drive Amgen's market share growth in the rare disease sector, further solidifying its leadership in the biopharmaceutical industry.
See More
Amgen's UPLIZNA Approved in Europe for Myasthenia Gravis Treatment
- New Drug Approval: Amgen's UPLIZNA (inebilizumab) has received approval from the European Commission as an adjunct treatment for adults with anti-AChR+ and anti-MuSK+ myasthenia gravis, marking a significant new treatment option for this rare disease.
- Significant Treatment Effects: UPLIZNA offers long-term disease control through a biannual maintenance dose, with studies showing that 87.4% of patients successfully reduced steroid doses to 5 mg or less daily within 26 weeks, greatly improving quality of life.
- Clinical Research Support: The approval of UPLIZNA is backed by positive results from the MINT study, the largest biological study for myasthenia gravis involving 238 patients, validating its safety and efficacy.
- Huge Market Potential: Myasthenia gravis affects approximately 56,000 to 123,000 people in Europe, and the launch of UPLIZNA not only provides patients with a new treatment option but also has the potential to reduce long-term reliance on steroids, enhancing Amgen's competitiveness in the biopharmaceutical market.
See More
European Pharma Companies Look Ahead to 2026
- Patent Cliff Challenge: Pharmaceutical companies are facing an impending patent cliff, with billions in sales at risk, particularly Novartis, which anticipates a $4 billion loss in the first half of 2025, compelling firms to invest heavily in new drug pipelines to offset revenue losses.
- Optimistic Pipeline Outlook: Companies like Novartis and AstraZeneca are emphasizing their robust drug pipelines, with Novartis projecting $59 billion in revenue for 2025 and AstraZeneca aiming for $80 billion by 2030, reflecting confidence in future growth despite current challenges.
- M&A Strategic Focus: As companies seek to replenish revenue through acquisitions, there is a growing emphasis on the Chinese market as a significant source of innovation, with the frequency of deals with Chinese firms increasing markedly over the past decade.
- Pricing Strategy Uncertainty: Although the immediate threat from Trump's Most Favored Nation drug pricing policy has diminished, pharmaceutical companies are still deliberating on how to balance pricing strategies between the U.S. and European markets to ensure market access and profitability for new drugs.
See More
UPLIZNA Approved in Europe for MGg Treatment
- New Treatment Option: UPLIZNA (inebilizumab) has been approved by the European Commission as an adjunct treatment for adults with anti-AChR+ and MuSK+ myasthenia gravis (MGg), offering a biannual maintenance dosage that may reduce long-term steroid use.
- Clinical Trial Support: The approval is backed by data from the MINT study involving 238 MGg patients, where 87.4% of UPLIZNA patients reduced their steroid dosage to 5 mg or less by week 26, demonstrating significant efficacy.
- Market Potential: With an estimated 56,000 to 123,000 individuals affected by MGg in Europe, the approval of UPLIZNA provides a new treatment option for this rare disease, potentially improving patients' quality of life significantly.
- Long-term Efficacy Expectations: By targeting CD19-positive B cells, UPLIZNA offers durable disease control, which may transform the treatment landscape for MGg and lessen patients' reliance on steroids, enhancing overall treatment outcomes.
See More
UPLIZNA Approved in Europe for gMG Treatment
- New Therapy Approval: Amgen announced that UPLIZNA (inebilizumab) has been approved by the European Commission as a new treatment option for adults with gMG who are anti-AChR+ and anti-MuSK+, marking a significant advancement in addressing this rare autoimmune disease.
- Long-Term Control Potential: UPLIZNA demonstrates the potential for long-term disease control through a semi-annual maintenance dose following two initial loading doses, which may reduce patients' reliance on long-term steroids, thereby improving their quality of life.
- Clinical Trial Support: The approval is backed by data from the MINT trial, the largest Phase 3 study for gMG, where 87.4% of UPLIZNA patients successfully reduced their steroid dosage to 5mg or less daily by week 26, showcasing its efficacy.
- Broad Market Prospects: The approval of UPLIZNA not only provides a new treatment option for gMG patients but also positions it to potentially play a significant role in the future market, especially regarding its potential against other autoimmune diseases, further solidifying Amgen's leadership in the biopharmaceutical sector.
See More
