Instant Report

Date: 27-Apr-2021

EMA Grants Accelerated Assessment Procedure For Calliditas’ Nefecon To Treat IgA Nephropathy

Calliditas Therapeutics AB (Calliditas) 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 of the application for marketing authorization to 150 days (excluding clock-stops). Calliditas expects to submit an MAA to the EMA in Q2 2021.

“We are very excited that CHMP has decided to grant us accelerated assessment, which supports the significant unmet medical need in IgAN.  We look forward to engaging with EMA over the coming months with the goal to be able to bring the first approved product to patients with IgAN as soon as possible,” said CEO Renée Aguiar-Lucander.

If approved, Nefecon could be available to patients in Europe in H1 2022 and would become the first therapy specifically designed and approved for the treatment of IgAN, and which has the potential to be disease modifying.

Calliditas Therapeutics is a biopharma company based in Stockholm, Sweden focused on identifying, developing and commercializing novel treatments in orphan indications, with an initial focus on renal and hepatic diseases with significant unmet medical needs.

Nefecon is a patented oral formulation of a potent and well-known active substance – budesonide – for targeted release.