STOCKHOLM, Sept. 14, 2021 /PRNewswire/ -- 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 U.S.
Food and Drug Administration (FDA) has extended the PDUFA goal date
for its New Drug Application (NDA) seeking accelerated approval for
Nefecon to December 15, 2021.
In March 2021 Calliditas filed for
FDA approval using the Accelerated Approval Program, based on the
proteinuria endpoint as previously discussed with the Agency,
reflecting data from the 200 patients in Part A of the NefIgArd
trial.
In its review of the NDA, the FDA has requested further analyses
of the NeflgArd trial data which the company has provided to the
FDA. The Agency has classified these analyses as a major amendment
to the NDA. The amendment mainly provides additional eGFR and other
related analyses as further support of the proteinuria data
provided in the NDA submission. The FDA has therefore extended the
PDUFA goal date to December 15,
2021.
"Our NDA for Nefecon is the first time that the FDA is
considering an approval on the basis of proteinuria as a surrogate
endpoint for accelerated approval in IgA nephropathy, requiring an
in-depth review process. We will continue to cooperate closely with
the FDA as they complete the review of our NDA," said Renée
Aguiar-Lucander, CEO at Calliditas.
For further information, please contact:
Renée Aguiar-Lucander, CEO at Calliditas
E-mail: renee.lucander@calliditas.com
Marie Galay, Corporate
Communications and IR
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 September 14, 2021 at 3:10
pm ET.
About Calliditas
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. Calliditas' lead
product candidate, Nefecon, is a proprietary, novel oral
formulation of budesonide, an established, highly potent local
immunosuppressant, for the treatment of adults with the autoimmune
renal disease primary IgA nephropathy (IgAN), for which there is a
high unmet medical need and there are no approved treatments.
Calliditas read out topline data from Part A of its global Phase 3
study in IgAN in November 2020 and,
if approved, aims to commercialize Nefecon in the United States. Calliditas is also planning
to start clinical trials with NOX inhibitors in primary biliary
cholangitis and head and neck cancer. Calliditas is listed on
Nasdaq Stockholm (ticker: CALTX) and the Nasdaq Global Select
Market (ticker: CALT).
Forward-looking statements
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 FDA approval of its regulatory
marketing application for Nefecon, the potential for FDA's review
extension on the NDA for Nefecon to lead to marketing approval,
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 Securities and Exchange
Commission. Calliditas cautions you not to place undue reliance on
any forward-looking statements, which speak only as of the date
they are made. Calliditas disclaims any obligation to publicly
update or revise any such statements to reflect any change in
expectations or in events, conditions or circumstances on which any
such statements may be based, or that may affect the likelihood
that actual results will differ from those set forth in the
forward-looking statements. Any forward-looking statements
contained in this press release represent Calliditas' views only as
of the date hereof and should not be relied upon as representing
its views as of any subsequent date.
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SOURCE Calliditas Therapeutics