MedPage Today

Complement Inhibitor Shows Promise for Rare Kidney Disorder

SAN DIEGO -- Intravenous ravulizumab (Ultomiris) yielded clinically meaningful reductions in IgA nephropathy-related proteinuria in a small, mid-stage trial. The 43 patients treated with ravulizumab ...
Seeking Alpha

Novartis receives FDA accelerated approval for Fabhalta® (iptacopan), the first and only complement inhibitor for the reduction of proteinuria in primary IgA nephropathy (IgAN)

East Hanover, N.J., Aug. 7, 2024 /PRNewswire/ -- Novartis today announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for Fabhalta ® (iptacopan), a first-in-class ...
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Dianthus: Improved Autoimmune Disorder Targeting With Classical Pathway Inhibition

Dianthus Therapeutics, Inc. (DNTH) is advancing its potential best-in-class complement inhibitor drug DNTH103 for a wide variety of autoimmune disorders. In particular, it is looking at advancing the ...
Nature

FDA approves first complement factor D inhibitor

The FDA has approved AstraZeneca’s danicopan (Voydeya) as add-on therapy to C5-targeted antibodies for extravascular haemolysis (EVH) in adults with paroxysmal nocturnal haemoglobinuria (PNH).
MedPage Today

FDA OKs Complement Inhibitor for IgA Nephropathy

The FDA granted accelerated approval to iptacopan (Fabhalta) for primary immunoglobulin A (IgA) nephropathy, a rare progressive disease where the immune system attacks the kidneys, Novartis announced ...
Business Insider

Novartis Receives FDA Accelerated Approval For Fabhalta As First Complement Inhibitor For IgAN

(RTTNews) - Novartis (NVS) announced that the U.S. Food and Drug Administration has granted accelerated approval for Fabhalta (iptacopan), a first-in-class complement inhibitor for the reduction of ...
Business Wire

FDA Grants Rare Pediatric Disease Designation to Omeros’ MASP-3 Inhibitor Zaltenibart for Treatment of C3 Glomerulopathy

SEATTLE--(BUSINESS WIRE)--Omeros Corporation today announced that zaltenibart (OMS906) has received rare pediatric disease designation from the U.S. Food and Drug Administration (FDA) for the ...
Medscape

Can New Drugs Better Control Breakthrough Hemolysis?

Researchers analyzed BTH definition, frequency, and severity across phase 3 clinical trials with terminal complement inhibitors (ravulizumab and crovalimab) and upstream complement inhibitors ...
Verywell Health on MSN

6 types of treatment for complement 3 glomerulopathy

Medically reviewed by Matthew Wosnitzer, MD Complement 3 glomerulopathy (C3G) is a rare kidney disease that is also ...
Morningstar

Annexon Reports Phase 1 Results for ANX1502, its Oral Small Molecule Inhibitor of the Classical Complement Pathway

“After more than a decade of groundbreaking research targeting the early classical complement pathway, we are excited to have reached an important step in the clinical development of ANX1502, our ...
Business Wire

FDA Grants Orphan Drug Designation to Omeros’ MASP-3 Inhibitor OMS906 for Treatment of Paroxysmal Nocturnal Hemoglobinuria

SEATTLE--(BUSINESS WIRE)--Omeros Corporation today announced that OMS906 has received orphan drug designation from the U.S. Food and Drug Administration (FDA) for the treatment of paroxysmal nocturnal ...