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Last Updated: January 8, 2025

CLINICAL TRIALS PROFILE FOR EXTAVIA


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All Clinical Trials for EXTAVIA

Trial ID Title Status Sponsor Phase Start Date Summary
NCT01466114 ↗ Estriol Treatment in Multiple Sclerosis (MS): Effect on Cognition Recruiting Synthetic Biologics (formerly Adeona Pharmaceuticals) Phase 2 2011-10-01 Approximately 50% of people diagnosed with Multiple Sclerosis (MS) will develop problems with cognition. Currently, there are no FDA-approved treatments targeting cognitive function in Multiple Sclerosis. This trial will ascertain whether treatment with an estrogen pill, used in combination with standard MS anti-inflammatory drugs, can improve cognitive testing as compared to treatment with a placebo pill in combination with standard anti-inflammatory drugs in women with MS.
NCT01466114 ↗ Estriol Treatment in Multiple Sclerosis (MS): Effect on Cognition Recruiting University of California, Los Angeles Phase 2 2011-10-01 Approximately 50% of people diagnosed with Multiple Sclerosis (MS) will develop problems with cognition. Currently, there are no FDA-approved treatments targeting cognitive function in Multiple Sclerosis. This trial will ascertain whether treatment with an estrogen pill, used in combination with standard MS anti-inflammatory drugs, can improve cognitive testing as compared to treatment with a placebo pill in combination with standard anti-inflammatory drugs in women with MS.
NCT01647880 ↗ MOdification of VIsual Outcomes After Optic Neuritis in CIS or MS by Gilenya (MOVING Study) Terminated NeuroCure Clinical Research Center Phase 2/Phase 3 2013-07-01 In the MOVING study should be examined, whether early therapeutic intervention with fingolimod (Gilenya ®) after optic neuritis(ON) has a favorable visual outcome as a comparative therapie with Interferon beta-1b (Extavia®), as measured by multifocal visual evoked potentials (mVEP) after 6 month compared to baseline.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for EXTAVIA

Condition Name

Condition Name for EXTAVIA
Intervention Trials
Multiple Sclerosis 1
Multiple Sclerosis, Primary Progressive 1
Multiple Sclerosis, Secondary Progressive 1
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Condition MeSH

Condition MeSH for EXTAVIA
Intervention Trials
Multiple Sclerosis 4
Sclerosis 3
Multiple Sclerosis, Chronic Progressive 2
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Clinical Trial Locations for EXTAVIA

Trials by Country

Trials by Country for EXTAVIA
Location Trials
United States 32
Germany 1
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Trials by US State

Trials by US State for EXTAVIA
Location Trials
Colorado 3
California 3
Washington 2
Texas 2
Tennessee 2
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Clinical Trial Progress for EXTAVIA

Clinical Trial Phase

Clinical Trial Phase for EXTAVIA
Clinical Trial Phase Trials
Phase 4 1
Phase 2/Phase 3 1
Phase 2 2
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Clinical Trial Status

Clinical Trial Status for EXTAVIA
Clinical Trial Phase Trials
Terminated 2
Completed 1
Recruiting 1
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Clinical Trial Sponsors for EXTAVIA

Sponsor Name

Sponsor Name for EXTAVIA
Sponsor Trials
Synthetic Biologics (formerly Adeona Pharmaceuticals) 1
University of California, Los Angeles 1
NeuroCure Clinical Research Center 1
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Sponsor Type

Sponsor Type for EXTAVIA
Sponsor Trials
Other 6
NIH 2
Industry 2
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EXTAVIA Market Analysis and Financial Projection

Extavia: Clinical Trials, Market Analysis, and Projections

Introduction to Extavia

Extavia, containing the active substance interferon beta-1b, is a medication authorized for the treatment of multiple sclerosis (MS), a chronic and often disabling autoimmune disease that affects the central nervous system. Here, we will delve into the clinical trials, market analysis, and projections for Extavia.

Clinical Trials and Efficacy

Extavia has been extensively studied in various clinical trials to assess its efficacy and safety in treating different forms of MS.

Relapsing-Remitting MS

In a two-year study involving 338 patients with relapsing-remitting MS, Extavia demonstrated a significant reduction in the number of annual relapses compared to placebo. Patients receiving Extavia had an average of 0.84 relapses per year, whereas those on placebo had 1.27 relapses per year[1][4].

Secondary Progressive MS

Extavia was also studied in 1,657 patients with secondary progressive MS in two separate trials. One of these studies showed a significant delay in the time to disability progression and in the time to becoming wheelchair-bound, with a 31% risk reduction due to Extavia. Both studies demonstrated a 30% reduction in the number of clinical relapses[1].

Early MS

A study involving 487 patients with a single demyelinating event showed that treatment with Extavia for two years reduced the risk of developing clinically defined MS. Only 28% of patients who received Extavia developed MS, compared to 45% of those who received placebo[1].

Mechanism of Action

Extavia works by calming down the immune system, which in MS, malfunctions and attacks the central nervous system. The exact mechanism is not fully understood, but interferon beta-1b is known to reduce inflammation and prevent relapses of MS[1].

Side Effects and Contraindications

Common side effects of Extavia include flu-like symptoms such as fever, chills, joint pain, and reactions at the site of injection. These side effects are more frequent at the beginning of treatment but tend to decrease over time. Extavia is contraindicated in patients with severe depression or thoughts of suicide and in those with decompensated liver disease[1].

Market Analysis

Global Market Size and Growth

The global multiple sclerosis drugs market, which includes Extavia, has been growing steadily. In 2016, the market was valued at $16.13 billion and is expected to reach $27.38 billion by 2025, growing at a CAGR of 6.3% from 2017 to 2025[2].

By 2028, the market is projected to reach $41.99 billion, maintaining a CAGR of 6.3% from 2021 to 2028[3].

Market Segmentation

The MS drugs market is segmented by route of administration, with parenteral drugs, including Extavia, holding the largest market share. This segment is driven by the sales of drugs like Avonex, Betaseron, Copaxone, and Rebif[2].

Regional Market

North America holds the largest share of the MS drugs market and is expected to show the fastest growth during the forecast period. This growth is driven by the rising incidence of MS, technological advances, and higher treatment compliance[2].

Market Projections

Future Trends

The market for MS drugs, including Extavia, is expected to continue growing due to several factors:

  • Rising Prevalence: The increasing prevalence of MS in some countries is driving the demand for effective treatments.
  • Technological Advances: Continuous advancements in treatment options, including the development of new small molecules and biologics, are expected to fuel market growth.
  • High Unmet Needs: The ongoing search for ideal treatments and the promising pipeline of new molecules will further drive the market[2][3].

Competitive Landscape

Extavia competes in a market dominated by other interferon beta products such as Avonex, Betaseron, and Rebif. However, its well-established safety and efficacy profile, along with the support programs offered by Novartis, make it a significant player in the market[4].

Support Programs and Accessibility

Novartis offers a comprehensive support program for Extavia patients, including a nurse helpline, one-on-one injection training, and reimbursement support services. An autoinjector is also available to facilitate self-administration of the drug[4].

Conclusion

Extavia is a crucial treatment option for patients with multiple sclerosis, backed by robust clinical trials that demonstrate its efficacy in reducing relapses and delaying disease progression. The global market for MS drugs is expected to grow significantly, driven by increasing prevalence, technological advancements, and high unmet needs. As a well-established treatment with a strong support program, Extavia is poised to remain a key player in the MS treatment landscape.

Key Takeaways

  • Efficacy: Extavia reduces the number of clinical relapses and delays disease progression in MS patients.
  • Market Growth: The global MS drugs market is projected to reach $41.99 billion by 2028, growing at a CAGR of 6.3%.
  • Market Segmentation: Parenteral drugs, including Extavia, dominate the market.
  • Regional Focus: North America holds the largest market share and is expected to show the fastest growth.
  • Support Programs: Novartis offers comprehensive support for Extavia patients, including training and reimbursement services.

FAQs

What is Extavia used for?

Extavia is used to treat adults with multiple sclerosis (MS), specifically relapsing forms of MS, early MS, and secondary progressive MS with relapses[1][4].

How is Extavia administered?

Extavia is administered via injection under the skin, with a recommended dose of 250 micrograms every other day. Patients can self-administer the drug after proper training[1].

What are the common side effects of Extavia?

Common side effects include flu-like symptoms such as fever, chills, joint pain, and reactions at the site of injection[1].

Is Extavia available in all regions?

Extavia is approved and available in several countries, including those in the European Union and the United States[1][4].

What support programs are available for Extavia patients?

Novartis offers a support program that includes a nurse helpline, one-on-one injection training, and reimbursement support services. An autoinjector is also available to facilitate self-administration[4].

Sources

  1. European Medicines Agency. Extavia | European Medicines Agency (EMA).
  2. Business Wire. Global $27.3 Billion Multiple Sclerosis Drugs Market 2017-2025.
  3. GlobeNewswire. With 6.3% CAGR, Multiple Sclerosis Drugs Market Size Worth USD 41.99 Billion in 2028.
  4. IOMSN. US FDA Approves Extavia.

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