Entyvio FDA Approval Status

When a therapy receives approval from the U.S. Food and Drug Administration (FDA), it means that the treatment has passed a thorough evaluation for safety, efficacy, and quality through rigorous clinical trials, along with continuous post-marketing monitoring. This process is especially vital for therapies aimed at treating chronic conditions or those involving the immune system.

One such therapy is Entyvio (vedolizumab), a gut-selective biologic that was first approved by the FDA in 2014 for the treatment of ulcerative colitis and Crohn’s disease. More recently, the FDA expanded its approval to include a subcutaneous formulation (approved in 2023–2024), giving patients more treatment options.

In this article, we’ll explore Entyvio’s FDA approval status, what indications it has been approved for, and how these milestones impact both patients and healthcare providers in managing IBD.

Key Takeaways

• Entyvio (vedolizumab) received FDA approval in 2014 for the treatment of moderate to severe ulcerative colitis and Crohn’s disease. It is gut-selective, meaning it targets inflammation specifically in the gastrointestinal tract without broadly suppressing the immune system.
• In 2023, the FDA approved the subcutaneous formulation of Entyvio, allowing patients to self-administer the medication at home after the initial IV induction phase.
• Entyvio offers a favorable safety profile, with minimal serious infections and no reported cases of PML in clinical trials and post-marketing studies.
• Post-marketing studies have demonstrated that Entyvio helps patients achieve sustained remission, reduces hospitalizations, and improves long-term outcomes.
• Entyvio’s unique mechanism reduces systemic infection risks and makes it an optimal treatment option for patients with IBD who require long-term management.

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Initial FDA Approval & Basis (2014)

Entyvio (vedolizumab) first received approval from the U.S. Food and Drug Administration (FDA) on May 20, 2014 for the treatment of moderate to severe ulcerative colitis (UC) and Crohn’s disease (CD). 

This approval followed the results of the GEMINI 1 and GEMINI 2 clinical trials, which demonstrated that vedolizumab was highly effective in reducing gut inflammation and promoting mucosal healing. It was especially beneficial for patients who had an inadequate response, loss of response, or were intolerant to corticosteroids, immunomodulators (e.g., thiopurines), or TNF blockers.

What makes Entyvio stand out from traditional treatments is its gut-selective mechanism. Unlike systemic immunosuppressants that broadly suppress the immune system, Entyvio targets inflammation specifically in the intestinal tract by blocking the α4β7 integrin from binding to MAdCAM-1 (Mucosal Addressin Cell Adhesion Molecule-1) on the gut lining. This prevents lymphocytes (white blood cells) from migrating to the gut, thus reducing inflammation without affecting the body’s overall immune response.

The initial FDA approval was based on Entyvio’s ability to deliver long-term remission rates with minimal severe infections or malignancies. As a result, Entyvio quickly became an important treatment strategy for patients who were unresponsive or intolerant to conventional therapies. The Entyvio dose schedule, which starts with induction infusions at Weeks 0, 2, and 6. Patients then move to maintenance doses every 8 weeks, supports both clinical monitoring and long-term adherence.

While some may wonder “Is Entyvio an immunosuppressant?”, both professionals and patients should remember that Entyvio is not a traditional immunosuppressant. Unlike many immunosuppressants that weaken the immune system throughout the body, Entyvio targets the gut specifically. It reduces inflammation where it starts while preserving immune function elsewhere.

European (EMA) and Global Regulatory Status

Following its FDA approval, Entyvio received formal marketing authorization from the European Medicines Agency (EMA) in May 2014, following a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) in March 2014. This authorization confirmed Entyvio’s role as a significant treatment for ulcerative colitis and Crohn’s disease in Europe.

The global regulatory journey of Entyvio includes key milestones such as:

• 2014: Approval from the EMA and Health Canada.
  
• 2015-2017: Expanded access in Japan, Australia, and South Korea.
  
• 2020s: Continued growth in Latin America and Southeast Asia.
  

These regulatory steps underscore Entyvio’s unique status as a gut-selective biologic. In clinical and real-world studies, patients treated with Entyvio experienced sustained remission rates and fewer systemic side effects than those treated with TNF blockers or corticosteroids. Data from the VARSITY trial for ulcerative colitis highlighted Entyvio’s superior performance in achieving long-term disease control, making it a key option for patients seeking effective treatment.

Recent FDA Label Expansions & SC Approval

In 2023, the FDA expanded Entyvio’s label to include a subcutaneous (SC) formulation, allowing patients to self-administer vedolizumab after completing the initial IV induction phase. This approval was a significant milestone, offering patients a more convenient and flexible treatment option that could be administered at home using pre-filled syringes or pens.

Significant Updates from the FDA Label Expansions

• 2023: Subcutaneous (SC) formulation approval for both ulcerative colitis (UC) and Crohn’s disease (CD) following IV induction.
  
• Real-world data: Positive outcomes based on long-term phase 3 studies and post-marketing surveillance.
  
• Enhanced accessibility: SC administration improves patient quality of life by reducing the need for frequent clinic visits.

The approval of Entyvio’s subcutaneous formulation has enabled patients to manage their treatment more independently, significantly improving adherence and flexibility. This option offers similar efficacy to the IV formulation while promoting steady disease control. The shift from hospital-based infusions to self-administered care represents a growing trend in biologic management, supporting both patient autonomy and convenience.

Post-Marketing Studies, Long-Term Safety & Real-World Use

Since its approval, Entyvio has undergone continuous post-marketing surveillance to evaluate its long-term safety and real-world efficacy. The results from these studies consistently support Entyvio’s favorable benefit-to-risk profile, with minimal serious adverse events compared to other biologics.

Some vital findings from long-term post-marketing studies include:

• Low incidence of serious infections compared to other systemic biologics.
  
• Minimal reports of malignancies or progressive multifocal leukoencephalopathy (PML). This rare complication is more common with some other integrin inhibitors (such as natalizumab). Fortunately, Entyvio’s gut-selective mechanism minimizes this risk.
  
• Sustained remission rates in long-term users, even beyond five years of therapy.
  
• Improved patient-reported outcomes and reduced hospitalization rates.

These findings further support Entyvio as a trusted treatment for ulcerative colitis and Crohn’s disease. Its ability to offer long-term remission with minimal risk of serious infections or complications makes it a valuable option for chronic disease management. Healthcare providers continue to rely on Entyvio for personalized treatment plans. This is primarily true for patients with comorbidities or those who are at higher risk of infections.

Conclusion

The FDA approval story of Entyvio reflects its ongoing scientific rigor, patient-centered care, and commitment to innovative biologic therapy. From its initial approval in 2014 to the most recent approval of its subcutaneous formulation in 2023, Entyvio has consistently demonstrated its value as a safe and effective treatment for ulcerative colitis and Crohn’s disease.

With its gut-selective action, Entyvio offers patients a treatment that minimizes systemic immune suppression while effectively controlling gastrointestinal inflammation. As ongoing studies continue to demonstrate positive long-term outcomes, Entyvio remains a cornerstone therapy in the management of IBD, setting the stage for the next generation of targeted biologic therapies.

FAQs

1. What year did Entyvio receive its initial FDA approval?

The FDA approved Entyvio in May 2014 for the treatment of moderate to severe ulcerative colitis and Crohn’s disease.

2. What is the latest FDA update regarding Entyvio?

The most recent update was the approval of the subcutaneous formulation in 2023. It allows self-administration after the initial IV loading doses.

3. How does Entyvio differ from systemic immunosuppressants?

Yes, inactivated vaccines are recommended. Live vaccines should be avoided. It’s important to complete all vaccinations before starting treatment for maximum protection.

References

Entyvio (vedolizumab) FDA Approval History. Drugs.com. https://www.drugs.com/history/entyvio.html

Takeda Pharmaceutical Company Limited. U.S. FDA Approves Subcutaneous Administration of Takeda’s ENTYVIO® (vedolizumab) for Maintenance Therapy in Moderately to Severely Active Crohn’s Disease. https://www.takeda.com/newsroom/newsreleases/2024/fda-approves-subcutaneous-administration-of-entyvio/

Ooi CJ, Hilmi IN, Kim HJ, et al. Efficacy and safety of vedolizumab in ulcerative colitis in patients from Asian countries in the GEMINI 1 study. Intest Res. 2021;19(1):71-82. doi:10.5217/ir.2019.09159

Banerjee R, Chuah SW, Hilmi IN, et al. Efficacy and safety of vedolizumab in Crohn’s disease in patients from Asian countries in the GEMINI 2 study. Intest Res. 2021;19(1):83-94. doi:10.5217/ir.2019.09160