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EMA Grants Accelerated Assessment Procedure for Nefecon for the Treatment of IgA Nephropathy News provided by Share this article STOCKHOLM, April 23, 2021 /PRNewswire/ Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) ( Calliditas ) today announced that its lead product candidate Nefecon, a novel oral formulation targeting down regulation of IgA1 for the treatment of primary IgA Nephropathy (IgAN), has been granted accelerated assessment procedure by the European Medicine Agency s (EMA) Committee for Human Medicinal Products (CHMP). Accelerated assessment, which may be granted when the CHMP concludes that the product is of major public health interest and major therapeutic innovation pursuant to Article 14 (9) of Regulation (EC) No 726/2004, reduces the timeframe for the EMA to review a marketing authorization application (MAA.) Typically, evaluating an MAA can take up to 210 procedure days, but accelerated assessment reduces the maximum timeframe for review

United statesMarie galayExchange commissionCommittee for human medicinal productsEuropean medicine agencyNasdaq stockholmIga nephropathyHuman medicinal productsNasdaq global select marketPrivate securities litigation reform actஒன்றுபட்டது மாநிலங்களில்பரிமாற்றம் தரகுகுழு க்கு மனிதன் மருத்துவ ப்ராடக்ட்ஸ்நாஸ்டாக் ஸ்டாக்‌ஹோல்ம்மனிதன் மருத்துவ ப்ராடக்ட்ஸ்நாஸ்டாக் உலகளாவிய தேர்ந்தெடுக்கவும் சந்தை