Firdapse (amifampridine) Report 2020: One of the First Drugs to be Approved for the Treatment of Lambert-Eaton Myasthenic Syndrome in Adults - Global Drug Insight and Market Forecast 2017-2030

Dublin, Dec. 30, 2020 (GLOBE NEWSWIRE) -- The "Firdapse (Amifampridine) - Drug Insight and Market Forecast - 2030" report has been added to ResearchAndMarkets.com's offering.

Firdapse (amifampridine) - Drug Insight and Market Forecast - 2030 report by the publisher outlays comprehensive insights of the product indicated for the treatment of its approved condition. A detailed picture of the Firdapse (amifampridine) in Seven Major Markets, i.e., United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan, for the study period 2017-2030 is provided in this report along with a detailed description of the product.

The product details cover mechanism of action, dosage and administration, route of synthesis, and pharmacological studies, including product marketed details, regulatory milestones, and other development activities. Further, it also consists of market assessments inclusive of the market forecast, SWOT analysis, and detailed analyst views. It further highlights the market competitors, late-stage emerging therapies, and patent details in the global space.

Firdapse (amifampridine) is one of the first drugs to be approved for the treatment of Lambert-Eaton myasthenic syndrome (LEMS) in adults. The drug was developed by BioMarin Pharmaceutical and is marketed by Catalyst Pharmaceutical, which secured the marketing rights to Firdapse in North America under a $5m deal in October 2012. The EU rights are retained by BioMarin. The European Commission (EC) granted marketing authorisation (MA) to Firdapse for the symptomatic treatment of LEMS in December 2009.

The drug also secured orphan drug designation in the EU. The US Food and Drug Administration (FDA) granted breakthrough therapy designation to the drug in August 2013. Catalyst Pharmaceutical submitted a new drug application (NDA) for Firdapse to the FDA in March 2018, and the application was accepted and granted priority review status in May of the same year. Firdapse was approved by the FDA in November 2018.

In-depth Firdapse (amifampridine) Market Assessment

This report provides a detailed market assessment of Firdapse (amifampridine) in Seven Major Markets, i.e., United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan. This segment of the report provides historical and forecasted sales data from 2017 to 2030.

Firdapse (amifampridine) Clinical Assessment

The report provides the clinical trials information of Firdapse (amifampridine) covering trial interventions, trial conditions, trial status, start and completion dates.

Report highlights

• In the coming years, the market scenario for Firdapse (amifampridine) is set to change due to the extensive research in the treatment of the indicated condition and incremental healthcare spending across the world; which would expand the size of the market to enable the drug manufacturers to penetrate more into the market.

• The companies and academics are working to assess challenges and seek opportunities that could influence Firdapse (amifampridine) dominance. The therapies under development are focused on novel approaches to treat/improve the disease condition.

• Other approved products for the disease are giving market competition to Firdapse (amifampridine) and launch of late-stage emerging therapies in the near future will significantly impact the market.

• A detailed description of regulatory milestones, development activities, and some key findings provide the current market scenario of Firdapse (amifampridine).

• Our in-depth analysis of the sales data of Firdapse (amifampridine) from 2017 to 2030 will support the clients in the decision-making process regarding their therapeutic portfolio by identifying the overall scenario of the Firdapse (amifampridine) in the market.

Key Topics Covered:

1. Product Overview
1.1. Indication
1.2. Mechanism of Action
1.3. Dosage and Administration
1.4. Dosage Forms and Strengths
1.4.1 Route of Synthesis
1.5. Pharmacology
1.5.1 Pharmacodynamics
1.5.2 Pharmacokinetics
1.6. Adverse Reactions
1.7. Product Snapshot
1.8. Development Milestones of Firdapse (amifampridine)
1.9. Marketed Details
1.9.1 United States
1.9.2 Europe
1.9.3 Japan
1.10. Patent Details

2. SWOT Analysis
2.1. Analyst Views

3. Regulatory Milestones
3.1. Approvals
3.2. Research and Development
3.3. Clinical Trials Information
3.4. Safety and Efficacy
3.5. Product Developmental Activities

4. Market Assessment
4.1. 7MM Market Analysis
4.2. United States
4.3. Europe
4.4. Japan
4.5. Key Findings

5. Market Competitors

6. Emerging Therapies

7. Appendix

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