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
If approved, Nefecon could be available to patients in
For further information, please contact:
E-mail: renee.lucander@calliditas.com
Tel.: +44 7955 129 845, e-mail: marie.galay@calliditas.com
The information in the press release is inside information that Calliditas is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact persons above, on
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This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, statements regarding Calliditas' strategy, business plans and focus. The words "may," "will," "could," "would," "should," "expect," "plan," "anticipate," "intend," "believe," "estimate," "predict," "project," "potential," "continue," "target" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, any related to Calliditas' business, operations, the potential for and timing of EMA approval of its regulatory marketing application for Nefecon, clinical trials, supply chain, strategy, goals and anticipated timelines, competition from other biopharmaceutical companies, and other risks identified in the section entitled "Risk Factors" in Calliditas' reports filed with the
https://news.cision.com/calliditas-therapeutics/r/updated-regulatory-timeline-for-review-of-maa-in-europe-,c3416583
https://mb.cision.com/Main/16574/3416583/1469252.pdf
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