KUVAN (Sapropterin Hydrochloride): Indicated to Reduce Blood Phe Levels in Patients with HPA Due to Tetrahydrobiopterin (BH4) Responsive PKU - Drug Market Insights and Market Forecast 2022-2032

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Jan 04, 2023, 14:30 ET

DUBLIN, Jan. 4, 2023 /PRNewswire/ -- The "KUVAN (Sapropterin Hydrochloride), Drug Insight and Market Forecast - 2032" report has been added to ResearchAndMarkets.com's offering.

"KUVAN (Sapropterin Hydrochloride), Drug Insight and Market Forecast - 2032" report provides comprehensive insights about KUVAN (Sapropterin Hydrochloride) for Phenylketonuria (PKU) in the 7MM.

A detailed picture of the KUVAN (Sapropterin Hydrochloride) for Phenylketonuria (PKU) in the 7MM, i.e., United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan, for the study period 2019-2032 is provided in this report along with a detailed description of the KUVAN (Sapropterin Hydrochloride) for Phenylketonuria (PKU).

The report provides insight about mechanism of action, dosage and administration, as well as research and development activity including regulatory milestones, along with other developmental activities.

Further, it also consists of future market assessments inclusive of the KUVAN (Sapropterin Hydrochloride) market forecast, analysis for Phenylketonuria (PKU) in the 7MM, descriptive analysis such as SWOT, analyst views, comprehensive overview of market competitors, and brief about other emerging therapies in Phenylketonuria (PKU).

Drug Summary

KUVAN is indicated to reduce blood phenylalanine (Phe) levels in patients with Hyperphenylalaninemia (HPA) due to tetrahydrobiopterin (BH4) responsive PKU and is to be used in conjunction with a Phe-restricted diet. In order to determine if there is a response to KUVAN, the recommended starting dose of KUVAN is 10 mg/kg/day taken once daily for up to a month.

If there is no response, the drug dose may be increased to 20 mg/kg/day for up to a month. The dose may be adjusted within a range of 5-20 mg/kg/day in patients who respond to KUVAN. KUVAN was developed in partnership with Merck Serono, a division of Merck.

Dosage and administration

All patients with PKU who are being treated with KUVAN should also be treated with a Phe-restricted diet, including dietary protein and Phe restriction.

Starting Dosage

Pediatric patients aged 1 month to 6 years: The recommended starting dose of KUVAN is 10 mg/kg is taken once daily.
Patients 7 years and older: The recommended starting dose of KUVAN is 10-20 mg/kg is taken once daily.

Dosage Adjustment

Doses of KUVAN may be adjusted in the range of 5-20 mg/kg, taken once daily.
Blood Phe is monitor regularly, especially in pediatric patients.

Mechanism of action

KUVAN is a synthetic form of BH4, the cofactor for the enzyme Phenylalanine Hydroxylase (PAH). PAH hydroxylates Phe through an oxidative reaction to form tyrosine. In patients with PKU, PAH activity is absent or deficient. Treatment with BH4 can activate residual PAH enzyme activity, improve the normal oxidative metabolism of Phe, and decrease Phe levels in some patients.

Scope of the Report

A comprehensive product overview including the KUVAN (Sapropterin Hydrochloride) description, mechanism of action, dosage and administration, research and development activities in Phenylketonuria (PKU).
Elaborated details on KUVAN (Sapropterin Hydrochloride) regulatory milestones and other development activities have been provided in this report.
The report also highlights the KUVAN (Sapropterin Hydrochloride) research and development activity in Phenylketonuria (PKU) in detail across the United States, Europe and Japan.
The report also covers the patents information with expiry timeline around KUVAN (Sapropterin Hydrochloride).
The report contains forecasted sales of KUVAN (Sapropterin Hydrochloride) for Phenylketonuria (PKU) till 2032.
Comprehensive coverage of the late-stage emerging therapies for Phenylketonuria (PKU).
The report also features the SWOT analysis with analyst views for KUVAN (Sapropterin Hydrochloride) in Phenylketonuria (PKU).

KUVAN (Sapropterin Hydrochloride) Analytical Perspective

In-depth KUVAN (Sapropterin Hydrochloride) Market Assessment

This report provides a detailed market assessment of KUVAN (Sapropterin Hydrochloride) in Phenylketonuria (PKU) in the 7MM, i.e., United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan. This segment of the report provides forecasted sales data from 2022 to 2032.

KUVAN (Sapropterin Hydrochloride) Clinical Assessment

The report provides the clinical trials information of KUVAN (Sapropterin Hydrochloride) in Phenylketonuria (PKU) covering trial interventions, trial conditions, trial status, start and completion dates.

Key Topics Covered:

1. Report Introduction

2. KUVAN (Sapropterin Hydrochloride)Overview
2.1. Product Detail
2.2. Clinical Development
2.2.1. Clinical Studies
2.2.2. Clinical Trials Information
2.2.3. Safety and Efficacy
2.3. Other Developmental Activities
2.4. Product Profile

3. Competitive Landscape (Marketed Therapies)

4. Competitive Landscape (Late-stage Emerging Therapies) *

5. KUVAN (Sapropterin Hydrochloride)Market Assessment
5.1. Market Outlook of KUVAN (Sapropterin Hydrochloride)in Phenylketonuria (PKU)
5.2. 7MM Market Analysis
5.2.1. Market Size of KUVAN (Sapropterin Hydrochloride) in the 7MM for Phenylketonuria (PKU)
5.3. Country-wise Market Analysis
5.3.1. Market Size of KUVAN (Sapropterin Hydrochloride) in the United States for Phenylketonuria(PKU)
5.3.2. Market Size of KUVAN (Sapropterin Hydrochloride) in Germany for Phenylketonuria (PKU)
5.3.3. Market Size of KUVAN (Sapropterin Hydrochloride) in France for Phenylketonuria (PKU)
5.3.4. Market Size of KUVAN (Sapropterin Hydrochloride) in Italy for Phenylketonuria (PKU)
5.3.5. Market Size of KUVAN (Sapropterin Hydrochloride) in Spain for Phenylketonuria (PKU)
5.3.6. Market Size of KUVAN (Sapropterin Hydrochloride) in the United Kingdom for Phenylketonuria (PKU)
5.3.7. Market Size of KUVAN (Sapropterin Hydrochloride) in Japan for Phenylketonuria (PKU)

6. SWOT Analysis

7. Analysts' Views

8. Appendix

For more information about this report visit https://www.researchandmarkets.com/r/5k0q0s

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