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Crucial Meetings With EMA Due For Travere/Vifor’s Sparsentan & Minoryx’s Leriglitazone

 
• By Vibha Sharma

Developers of three new drugs, including two orphan medicines, that are nearing the final stages of their EU regulatory review cycle could be asked to explain why the European Medicines Agency should recommend approval of their products.

Conference chair on wood table, black leather chair in meeting room decorated with modern white walls and wooden floor
CHMP oral explanation meetings are typically held towards the end of a product’s regulatory review cycle • Source: Shutterstock

Sponsors of sparsentan, leriglitazone and pegcetacoplan were this week due or possibly due to appear before the European Medicines Agency to explain why their respective drugs, which are in the late stages of the regulatory review cycle, merit pan-EU approval.

Sparsentan is Travere Therapeutics/CSL Vifor’s non-immunosuppressive therapy for treating primary immunoglobulin A nephropathy (IgAN), and leriglitazone is Minoryx Therapeutics’ novel blood-brain barrier-penetrant PPARγ agonist for the

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