Tricida Receives Complete Response Letter from the FDA for its New Drug Application for Veverimer for the Treatment of Metabo...
August 24 2020 - 8:30AM
Business Wire
Tricida, Inc. (Nasdaq: TCDA), a pharmaceutical company focused
on the development and commercialization of its drug candidate,
veverimer (TRC101), a non-absorbed, orally-administered polymer
designed to treat metabolic acidosis in patients with chronic
kidney disease (CKD), announced today that it received a Complete
Response Letter (CRL) from the U.S. Food and Drug Administration
(FDA) for its New Drug Application (NDA) for veverimer on August
21, 2020. The NDA was reviewed under the Accelerated Approval
Program.
According to the CRL, the FDA is seeking additional data beyond
the TRCA-301 and TRCA-301E trials regarding the magnitude and
durability of the treatment effect of veverimer on the surrogate
marker of serum bicarbonate and the applicability of the treatment
effect to the U.S. population. FDA also expressed concern as to
whether the demonstrated effect size would be reasonably likely to
predict clinical benefit. There were no safety, clinical
pharmacology/biopharmaceutics, CMC or non-clinical issues
identified in the CRL.
The CRL provided multiple options for resolving the identified
deficiencies. In order to obtain approval for veverimer the company
may or may not have to conduct an additional clinical trial. The
FDA indicated it is willing to meet with Tricida to discuss options
for obtaining approval, including under the Accelerated Approval
Program.
“We have collaborated with the FDA on the Accelerated Approval
Program for veverimer and while we are disappointed to receive this
CRL, we are pleased that the FDA has provided helpful, specific
comments and indicated their willingness to continue to work with
us to pursue approval of veverimer,” said Gerrit Klaerner, Ph.D.,
Tricida’s Chief Executive Officer and President. “We remain
confident in the fundamentals of, and unmet medical need for,
veverimer and we continue to conduct our confirmatory trial,
VALOR-CKD.”
Tricida plans to request a Type A meeting with the FDA in the
coming weeks. A Type A meeting is usually scheduled within 30 days
of the meeting request. Following the Type A meeting, anticipated
early in the fourth quarter, Tricida plans to provide an update on
next steps and estimated timing of a potential resubmission of the
NDA.
Tricida notes that cash, cash equivalents and investments were
$437 million at the end of the second quarter of 2020. Based on the
current operating plan, the company believes that it is well
positioned financially to fund its operations into early 2022.
About Tricida
Tricida, Inc. is a pharmaceutical company focused on the
development and commercialization of its drug candidate, veverimer
(TRC101), a non-absorbed, orally-administered polymer designed to
treat metabolic acidosis in patients with CKD. Tricida is currently
conducting its confirmatory postmarketing trial, VALOR-CKD, of
veverimer. The Tricida NDA for veverimer was submitted to the FDA
for review through the Accelerated Approval Program in August 2019.
A CRL was received from the FDA in August 2020. There are no
FDA-approved treatments for chronic metabolic acidosis, a condition
commonly caused by CKD that is believed to accelerate the
progression of kidney deterioration. It is estimated to pose a
health risk to approximately three million patients with CKD in the
United States.
For more information about Tricida, please visit www.Tricida.com.
Cautionary Note on Forward-Looking Statements
This press release includes forward-looking statements within
the meaning of Section 27A of the Securities Act and Section 21E of
the Securities Exchange Act of 1934 (“Exchange Act”).
Forward-looking statements relate to expectations concerning
matters that are not historical facts. Words such as “projects,”
“believes,” “anticipates,” “plans,” “expects,” “intends,” “may,”
“will,” “could,” “should,” “would,” and similar words and
expressions are intended to identify forward-looking statements.
Any statements contained herein which do not describe historical
facts, including the Company’s expectations with regard to its
interactions and communications with the FDA and its plans and
expectations as to the pathway to approval of veverimer by the FDA
are forward-looking statements which involve risks and
uncertainties that could cause actual results to differ materially
from those discussed in such forward-looking statements. Such risks
and uncertainties include, without limitation, whether the Company
will be able to address the deficiencies identified by FDA, whether
additional trials will be necessary, the availability of the
Accelerated Approval Program, the receipt and timing of regulatory
approval for veverimer, the Company’s ability to market and sell
veverimer, if approved, the Company’s ability to manufacture
veverimer, and risks associated with the Company’s business
prospects, financial results and business operations. These and
other factors that may affect the Company’s future business
prospects, results and operations are identified and described in
more detail in the Company’s filings with the Securities and
Exchange Commission (the “SEC”), including the Company’s most
recent Annual Report filed on Form 10-K and the subsequently filed
Quarterly Report(s) on Form 10-Q. You should not place undue
reliance on these forward-looking statements, which speak only as
of the date of this filing. Except as required by applicable law,
the Company does not intend to update any of the forward-looking
statements to conform these statements to actual results, later
events or circumstances or to reflect the occurrence of
unanticipated events.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20200824005200/en/
Jackie Cossmon Tricida, Inc. Senior Vice President of Investor
Relations and Communications IR@Tricida.com
Tricida (NASDAQ:TCDA)
Historical Stock Chart
From Mar 2024 to Apr 2024
Tricida (NASDAQ:TCDA)
Historical Stock Chart
From Apr 2023 to Apr 2024