SteadyMed Receives Refusal to File Letter from FDA for Trevyent® New Drug Application
August 31 2017 - 5:45AM
SteadyMed Ltd. (Nasdaq:STDY), a specialty pharmaceutical company
focused on the development of drug product candidates to treat
orphan and high-value diseases with unmet parenteral delivery
needs, today announced receipt of a Refusal to File letter from the
U.S. Food and Drug Administration (FDA) relating to its New Drug
Application (NDA) for Trevyent® for the treatment of Pulmonary
Arterial Hypertension (PAH).
Based on a preliminary review of the NDA, which
was submitted in June 2017, the FDA determined that the application
is not sufficiently complete to permit a substantive review. FDA
has requested further information on certain device specifications
and performance testing and has requested additional design
verification and validation testing on the final, to-be-marketed
Trevyent product. Within the next 30 days, the Company will request
a Type A meeting with the FDA to gain further clarification on the
additional information required for resubmission and acceptance of
the NDA. The Company will provide further guidance after the
anticipated meeting with FDA.
“We believe that the issues raised in the letter
from FDA can be sufficiently addressed. Our next step is to work
with the FDA to address the open issues and identify a path to a
successful resubmission and acceptance of our application,” said
Jonathan M. N. Rigby, President and CEO of SteadyMed. “We believe
that Trevyent holds the potential to significantly improve the
lives of patients suffering from PAH compared to the current
standard of care, and remain committed to bringing the product to
patients in need.”
Designed to address the limitations of existing
PAH therapies, SteadyMed’s investigational drug product Trevyent,
combines its preservative-free, parenteral treprostinil formulation
with the Company’s proprietary PatchPump®, in a sterile,
pre-filled, pre-programmed, single use disposable infusion system
capable of delivering treprostinil subcutaneously or
intravenously.
About SteadyMed
SteadyMed Ltd. is a specialty pharmaceutical
company focused on the development of drug products to treat orphan
and high value diseases with unmet parenteral delivery needs.
SteadyMed intends to commercialize Trevyent in the U.S. and has
signed an exclusive license and supply agreement with Cardiome
Pharma Corp. for the commercialization of Trevyent in Europe,
Canada and the Middle East. SteadyMed has
offices in San Ramon, California and Rehovot, Israel. For
additional information about SteadyMed please visit
www.steadymed.com.
Forward Looking Statements
This press release contains forward-looking
statements within the meaning of the Private Securities Litigation
Reform Act of 1995. Forward-looking statements include, among
others, statements about the company's intentions to meet with the
FDA and re-submit its New Drug Application for Trevyent and the
company’s ability to advance its development-stage product
candidates, including Trevyent. Forward-looking statements reflect
the company's current views with respect to certain current and
future events and are subject to various risks, uncertainties and
assumptions that could cause actual results to differ materially.
Risks and uncertainties include, but are not limited to, the risk
that Trevyent does not demonstrate clinical superiority to existing
parenteral treprostinil products, that the Trevyant NDA is not
accepted for filing by the FDA, that Trevyent is not approved for
commercialization by the FDA or approval is delayed by patent
litigation, the risk that drug development involves a lengthy and
expensive process with uncertain outcome, that the company will
continue to need additional funding, and that the company may be
unable to raise capital when needed, which would force the company
to delay, reduce or eliminate its product candidate development
programs and potentially cease operations. The risks, uncertainties
and assumptions referred to above are discussed in detail in our
reports filed with the Securities and Exchange Commission,
including our Quarterly Report on Form 10-Q filed on August 11,
2017. The company does not undertake to publicly update or revise
any forward-looking statements to reflect events or circumstances
that may arise after the date hereof except as may be required by
law.
Contacts:
Marylyn Rigby
Senior Director, Investor Relations and Marketing
925-272-4999
mrigby@steadymed.com
The Ruth Group
Lee Roth
(646) 536-7012
lroth@theruthgroup.com
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