Benzinga | Sep 16, 2021 08:54AM EDT

Calliditas Therapeutics Announces European Medicine Agency's Committee For Human Medicinal Products Has Decided To 'continue the assessment of the marketing authorization application (MAA) for Nefecon under standard procedure assessment timelines.'

Calliditas Therapeutics AB (publ) ("Calliditas" or the "Company") (Nasdaq Stockholm: CALTX) (NASDAQ:CALT), a biopharma company focused on identifying, developing and commercializing novel treatments in orphan indications, today announced that the European Medicine Agency's (EMA) Committee for Human Medicinal Products (CHMP)) has decided to continue the assessment of the marketing authorization application (MAA) for Nefecon under standard procedure assessment timelines.

Calliditas was in April, 2021 granted an accelerated assessment procedure on its MAA for Nefecon in IgA Nephropathy and submitted the MAA in May of 2021. With the revised standard assessment timeline Calliditas estimates a potential impact of 3 months on the previously communicated timelines with an expected decision by EMA in the first quarter, 2022.

"This is the first time that EMA is assessing an application for conditional approval in IgA nephropathy and we acknowledge the need for an in depth review under standard assessment timelines. We look forward to engaging with the agency to achieve a potential approval for this very deserving patient population as soon as possible." said Ren?e Aguiar-Lucander, CEO at Calliditas.

If approved, Nefecon could be available to patients in Europe in mid-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.