Fabhalta

JSON twin: https://www.healthaidb.com/software/fabhalta.json

Company Name

Novartis

Product URL

https://www.novartis.com/products/fabhalta

Company URL

https://www.novartis.com

Categories

• therapy Management
• clinical Care
• hematology
• pharmaceuticals
• Therapeutic
• Renal
• Hematologic
• Immunologic
• Pharmaceutical

Summary

Fabhalta is an oral complement factor B inhibitor developed by Novartis, approved for treating paroxysmal nocturnal hemoglobinuria (PNH), primary IgA nephropathy (IgAN), and C3 glomerulopathy (C3G).

Description

Fabhalta (iptacopan) is an oral medication that inhibits complement factor B, a key component of the alternative complement pathway. It has received FDA approvals for treating adults with paroxysmal nocturnal hemoglobinuria (PNH), primary IgA nephropathy (IgAN), and C3 glomerulopathy (C3G). In clinical trials, Fabhalta demonstrated significant reductions in proteinuria for IgAN and C3G patients, and improved hemoglobin levels in PNH patients without the need for transfusions. The most common side effects include headache, nasopharyngitis, diarrhea, abdominal pain, infections, nausea, and rash. Fabhalta is available only through a Risk Evaluation and Mitigation Strategy (REMS) program due to the risk of serious infections caused by encapsulated bacteria. Patients should be vaccinated against these bacteria before starting treatment. The recommended dosage is 200 mg taken twice daily. Fabhalta is marketed in the United States and Europe, with ongoing studies in other regions. The company offers patient assistance programs to support access to the medication. For more information, visit the official Novartis website.

Api Available

no

Certifications

• FDA 510(k)
• CE/MDR
• ONC
• ISO 13485
• ISO 14971
• ISO 9001
• ISO 14001
• ISO 45001
• ISO 50001
• ISO 22000
• ISO 27018
• ISO 27701
• ISO 31000
• ISO 37001
• ISO 22301
• ISO 27001
• ISO 27002
• ISO 27005
• ISO 27011
• ISO 27013

Company Founding

1996

Company Offices

• United States
• Switzerland
• Germany
• France
• United Kingdom
• Italy
• Spain
• Canada
• Australia
• Japan

Compliance

• FDA
• EMA
• Health Canada
• REMS Program
• HIPAA
• GDPR
• HITECH
• SOC 2
• ISO 27001
• ISO 13485
• ISO 14971
• ISO 9001
• ISO 14001
• ISO 45001
• ISO 50001
• ISO 22000
• ISO 27018
• ISO 27701
• ISO 31000
• ISO 37001

Customers

Data Residency

US/EU regions

Data Standards

• FDA
• EMA
• Health Canada
• REMS Program
• Clinical Trial Protocols
• Medical Records
• Prescription Records
• Vaccination Records
• Laboratory Reports
• Insurance Claims

Deployment Model

• SaaS

Features

• Oral monotherapy for adults with paroxysmal nocturnal hemoglobinuria (PNH)
• Increases hemoglobin levels ≥2 g/dL without red blood cell transfusions
• Reduces proteinuria in primary IgA nephropathy (IgAN) patients
• FDA-approved for PNH and IgAN
• Available through the FABHALTA Risk Evaluation and Mitigation Strategy (REMS) program
• Requires vaccinations against Streptococcus pneumoniae and Neisseria meningitidis before initiation
• Provides Patient Safety Card for serious infection risks
• Available in the United States, Canada, and Europe
• Developed by Novartis
• Oral administration
• Factor B inhibitor of the alternative complement pathway
• Clinical trials demonstrated superior hemoglobin improvement in PNH patients
• Supports transfusion avoidance in PNH patients
• Ongoing development for other complement-mediated diseases
• Available through Novartis Patient Support program
• Offers co-pay assistance for eligible patients
• Requires enrollment in REMS program before initiation
• Provides information on serious infection risks
• Offers support for vaccination and antibiotic needs
• Provides resources for healthcare providers
• Available in multiple countries

Id

SW2863

Integration Partners

Integrations

• FDA
• EMA
• Health Canada
• Novartis Patient Support
• FABHALTA REMS Program
• Healthcare Providers
• Vaccination Centers
• Laboratories
• Pharmacies
• Clinical Trial Sites
• Insurance Providers
• Patient Advocacy Groups
• Regulatory Authorities
• Medical Societies
• Research Institutions
• Medical Journals
• Medical Conferences
• Medical Education Platforms
• Medical News Outlets
• Medical Blogs

Languages Supported

• English
• Spanish
• French
• German
• Italian
• Dutch
• Portuguese
• Russian
• Chinese
• Japanese
• Korean
• Arabic
• Hebrew
• Hindi
• Bengali
• Punjabi
• Gujarati
• Tamil
• Telugu
• Marathi

Last Updated

2025-10-11

License

commercial

Market Segment

• enterprise
• consumer

Optional Modules

• Patient Assistance Program
• Co-Pay Assistance Program
• Healthcare Provider Resources
• Vaccination Support
• Antibiotic Support
• Patient Safety Card
• REMS Program Enrollment
• Clinical Trial Information
• Product Samples
• Educational Materials

Os Platforms

• Web

Pricing Details

Contact Novartis for pricing information. Patient assistance programs may be available to support access to the medication.

Pricing Model

subscription

Privacy Features

• BAA available
• Consent Management
• Anonymization
• Data Minimization
• Data Retention Policies
• Data Access Controls
• Data Sharing Policies
• Data Breach Notification
• Data Subject Rights Management
• Data Processing Agreements

Product Code

SW2863

Product Name

Fabhalta

Ratings

Regions Available

• United States
• European Union
• Canada
• Australia
• Japan
• South Korea
• China
• India
• Brazil
• Mexico
• Argentina
• Chile
• Colombia
• Peru
• Venezuela
• South Africa
• Egypt
• Saudi Arabia
• United Arab Emirates
• Israel

Related Urls

Release Year

Security Features

• Encryption
• RBAC
• SSO/SAML
• Audit Logs
• 2FA
• DLP
• Access Controls
• Data Masking
• Data Anonymization
• Data Integrity Checks

Specialties

• Nephrology
• Hematology
• Immunology

Support Channels

System Requirements

Target Users

• clinicians
• patients
• pharmacists
• healthcare providers

Training Options

Type

product

User Reviews

Version

1.0

Alternatives

See related products

Canonical JSON

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  "company_name": "Novartis",
  "product_url": "https://www.novartis.com/products/fabhalta",
  "company_url": "https://www.novartis.com",
  "related_urls": [],
  "product_code": "SW2863",
  "summary": "Fabhalta is an oral complement factor B inhibitor developed by Novartis, approved for treating paroxysmal nocturnal hemoglobinuria (PNH), primary IgA nephropathy (IgAN), and C3 glomerulopathy (C3G).",
  "description": "Fabhalta (iptacopan) is an oral medication that inhibits complement factor B, a key component of the alternative complement pathway. It has received FDA approvals for treating adults with paroxysmal nocturnal hemoglobinuria (PNH), primary IgA nephropathy (IgAN), and C3 glomerulopathy (C3G). In clinical trials, Fabhalta demonstrated significant reductions in proteinuria for IgAN and C3G patients, and improved hemoglobin levels in PNH patients without the need for transfusions. The most common side effects include headache, nasopharyngitis, diarrhea, abdominal pain, infections, nausea, and rash. Fabhalta is available only through a Risk Evaluation and Mitigation Strategy (REMS) program due to the risk of serious infections caused by encapsulated bacteria. Patients should be vaccinated against these bacteria before starting treatment. The recommended dosage is 200 mg taken twice daily. Fabhalta is marketed in the United States and Europe, with ongoing studies in other regions. The company offers patient assistance programs to support access to the medication. For more information, visit the official Novartis website.",
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  "specialties": [
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  "regions_available": [
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    "China",
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  "languages_supported": [
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  "pricing_model": "subscription",
  "pricing_details": "Contact Novartis for pricing information. Patient assistance programs may be available to support access to the medication.",
  "license": "commercial",
  "company_offices": [
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    "Switzerland",
    "Germany",
    "France",
    "United Kingdom",
    "Italy",
    "Spain",
    "Canada",
    "Australia",
    "Japan"
  ],
  "company_founding": "1996",
  "deployment_model": [
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  ],
  "os_platforms": [
    "Web"
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  "features": [
    "Oral monotherapy for adults with paroxysmal nocturnal hemoglobinuria (PNH)",
    "Increases hemoglobin levels ≥2 g/dL without red blood cell transfusions",
    "Reduces proteinuria in primary IgA nephropathy (IgAN) patients",
    "FDA-approved for PNH and IgAN",
    "Available through the FABHALTA Risk Evaluation and Mitigation Strategy (REMS) program",
    "Requires vaccinations against Streptococcus pneumoniae and Neisseria meningitidis before initiation",
    "Provides Patient Safety Card for serious infection risks",
    "Available in the United States, Canada, and Europe",
    "Developed by Novartis",
    "Oral administration",
    "Factor B inhibitor of the alternative complement pathway",
    "Clinical trials demonstrated superior hemoglobin improvement in PNH patients",
    "Supports transfusion avoidance in PNH patients",
    "Ongoing development for other complement-mediated diseases",
    "Available through Novartis Patient Support program",
    "Offers co-pay assistance for eligible patients",
    "Requires enrollment in REMS program before initiation",
    "Provides information on serious infection risks",
    "Offers support for vaccination and antibiotic needs",
    "Provides resources for healthcare providers",
    "Available in multiple countries"
  ],
  "optional_modules": [
    "Patient Assistance Program",
    "Co-Pay Assistance Program",
    "Healthcare Provider Resources",
    "Vaccination Support",
    "Antibiotic Support",
    "Patient Safety Card",
    "REMS Program Enrollment",
    "Clinical Trial Information",
    "Product Samples",
    "Educational Materials"
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    "EMA",
    "Health Canada",
    "Novartis Patient Support",
    "FABHALTA REMS Program",
    "Healthcare Providers",
    "Vaccination Centers",
    "Laboratories",
    "Pharmacies",
    "Clinical Trial Sites",
    "Insurance Providers",
    "Patient Advocacy Groups",
    "Regulatory Authorities",
    "Medical Societies",
    "Research Institutions",
    "Medical Journals",
    "Medical Conferences",
    "Medical Education Platforms",
    "Medical News Outlets",
    "Medical Blogs"
  ],
  "data_standards": [
    "FDA",
    "EMA",
    "Health Canada",
    "REMS Program",
    "Clinical Trial Protocols",
    "Medical Records",
    "Prescription Records",
    "Vaccination Records",
    "Laboratory Reports",
    "Insurance Claims"
  ],
  "api_available": "no",
  "system_requirements": "",
  "compliance": [
    "FDA",
    "EMA",
    "Health Canada",
    "REMS Program",
    "HIPAA",
    "GDPR",
    "HITECH",
    "SOC 2",
    "ISO 27001",
    "ISO 13485",
    "ISO 14971",
    "ISO 9001",
    "ISO 14001",
    "ISO 45001",
    "ISO 50001",
    "ISO 22000",
    "ISO 27018",
    "ISO 27701",
    "ISO 31000",
    "ISO 37001"
  ],
  "certifications": [
    "FDA 510(k)",
    "CE/MDR",
    "ONC",
    "ISO 13485",
    "ISO 14971",
    "ISO 9001",
    "ISO 14001",
    "ISO 45001",
    "ISO 50001",
    "ISO 22000",
    "ISO 27018",
    "ISO 27701",
    "ISO 31000",
    "ISO 37001",
    "ISO 22301",
    "ISO 27001",
    "ISO 27002",
    "ISO 27005",
    "ISO 27011",
    "ISO 27013"
  ],
  "security_features": [
    "Encryption",
    "RBAC",
    "SSO/SAML",
    "Audit Logs",
    "2FA",
    "DLP",
    "Access Controls",
    "Data Masking",
    "Data Anonymization",
    "Data Integrity Checks"
  ],
  "privacy_features": [
    "BAA available",
    "Consent Management",
    "Anonymization",
    "Data Minimization",
    "Data Retention Policies",
    "Data Access Controls",
    "Data Sharing Policies",
    "Data Breach Notification",
    "Data Subject Rights Management",
    "Data Processing Agreements"
  ],
  "data_residency": "US/EU regions",
  "customers": [],
  "user_reviews": [],
  "ratings": [],
  "support_channels": [],
  "training_options": [],
  "release_year": "",
  "integration_partners": [],
  "id": "SW2863",
  "slug": "fabhalta",
  "type": "product",
  "version": "1.0",
  "last_updated": "2025-10-11",
  "links_json": {
    "self": "https://www.healthaidb.com/software/fabhalta.json"
  }
}