Monomethyl fumarate
- Generic Name
- Monomethyl fumarate
- Brand Names
- Bafiertam
- Drug Type
- Small Molecule
- Chemical Formula
- C5H6O4
- CAS Number
- 2756-87-8
- Unique Ingredient Identifier
- 45IUB1PX8R
Lupus Nephritis Market Expected to Grow as Novel Therapies Enter Clinical Trials
• The global lupus nephritis market is projected to grow significantly by 2034, with the United States accounting for over 80% of the current $1.12 billion market share across major regions.
• Several innovative therapies are advancing through clinical trials, including CAR-T cell treatments from companies like Allogene Therapeutics, Adicet Bio, and Caribou Biosciences, which received FDA Fast Track designations.
• Key pharmaceutical players including Aurinia Pharmaceuticals, AstraZeneca, and Roche are developing treatments such as voclosporin, anifrolumab, and obinutuzumab to address the significant unmet needs in lupus nephritis management.
NICE Approves Biogen's Vumerity for Relapsing-Remitting Multiple Sclerosis with Improved Tolerability Profile
• NICE has recommended Biogen's oral therapy Vumerity (diroximel fumarate) for routine NHS use in patients with relapsing-remitting multiple sclerosis across England, Wales, and Northern Ireland.
• Clinical data shows Vumerity matches Tecfidera's efficacy while demonstrating significantly lower gastrointestinal side effects, with only 1% treatment discontinuation rate compared to 5% for Tecfidera.
• The approval represents a significant milestone for Biogen as Vumerity aims to succeed Tecfidera, which has seen declining sales due to generic competition, with US sales reaching $409 million compared to Tecfidera's $681 million.
Lupkynis (Voclosporin) Approved in Japan for Lupus Nephritis Treatment
• The Japanese Ministry of Health, Labour, and Welfare approved Lupkynis (voclosporin) in combination with mycophenolate mofetil for treating lupus nephritis.
• This approval was based on the AURORA Clinical Program, which demonstrated Lupkynis' efficacy and safety in treating lupus nephritis patients.
• Aurinia Pharmaceuticals is eligible to receive a $10 million payment from Otsuka Pharmaceutical, along with royalties on net sales, following the approval.
• Lupkynis, a second-generation calcineurin inhibitor, is now approved in Japan, the U.S., the U.K., the European Union, and Switzerland for lupus nephritis.
FDA Grants Full Approval to Travere's Filspari for IgA Nephropathy
• The FDA granted full approval to Travere Therapeutics' Filspari (sparsentan) for IgA nephropathy, allowing broader use for patients at risk of disease progression.
• The approval was based on the PROTECT study, which demonstrated Filspari significantly slowed kidney function decline over two years compared to irbesartan.
• Filspari is now positioned as a foundational, non-immunosuppressive treatment option, potentially replacing the current standard of care for IgAN patients.
• The label update removes a specific urine protein level requirement, expanding the eligible patient population and increasing Filspari's market potential.
Drug Development Updates
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