Shots:
The global P-III (ALIGN) trial assessed Vanrafia (0.75mg, QD, PO) vs PBO for 132wks. in 340 IgAN pts at risk of progressive loss of kidney function. An additional 64 pts received an SGLT2 inhibitor alongside a RAS inhibitor for at least 12wks.
In the trial, Vanrafia showed a 2.39 mL/min/1.73m² difference in eGFR change…
Novartis Highlights P-III (APPLAUSE-IgAN) Trial Findings on Fabhalta (Iptacopan) for IgA Nephropathy
Shots:
Novartis has reported the P-III (APPLAUSE-IgAN) trial findings assessing Fabhalta (200mg; BID; PO) vs PBO, both on top of SoC in 477 adults with IgA nephropathy (IgAN)
Trial showed that Fabhalta reduced IgAN progression measured by annualized total slope of eGFR decline over 2yrs., & demonstrated favorable safety; data to be used for 2026…
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The CHMP has granted positive opinion to CSL (exclusive commercialization rights holder in the EU, Australia & New Zealand) & Travere’s sparsentan for its conditional approval to treat primary IgAN with a urine protein excretion >1.0 g/day. EC’s decision is anticipated in Q2’24Â
The opinion was supported by the P-III (PROTECT) trial investigating the…
Shots:
To create a wholesome environment for the current and the future generation, it’s totally up to life science companies and decision-makers to embrace and integrate every prospect of the underlying disease conditions and address those issues to find cures
PharmaShots brings this month an informative take on the disease IgA nephropathy
Often known as…
Shots:
Dr. Richard talked about the results from the NefIgArd P-III trial evaluating Tarpeyo (Nefecon) for the treatment of IgA NephropathyÂ
He also highlighted the safety and efficacy results from the NefIgArd study. He also spoke more about Trapeyo and the roadmap for its global approval and commercializationÂ
The interview shows up how Calliditas is…

