Edge Therapeutics Receives Pediatric Investigation Plan Waiver from the European Medicines Agency
June 08 2017 - 6:30AM
Edge Therapeutics, Inc. (Nasdaq:EDGE), a clinical-stage
biotechnology company developing novel hospital-based therapies in
the management of acute, life-threatening conditions, today
announced that it received a product-specific pediatric waiver from
the European Medicines Agency (EMA) for EG-1962, Edge's lead
product candidate, which is currently in Phase 3 clinical
development for the treatment of aneurysmal subarachnoid hemorrhage
(aSAH). The European pediatric waiver for EG-1962 applies to all
subsets of the pediatric population.
“This waiver represents an important milestone in the regulatory
process in Europe, and will allow Edge to submit a marketing
authorization application for EG-1962 to the EMA following
completion of the Phase 3 NEWTON 2 study, without the requirement
to conduct clinical studies in a pediatric population either
pre-approval or post-approval,” said Brian A. Leuthner, Edge’s
President and Chief Executive Officer.
As part of the regulatory process for the registration of new
medicines with the EMA, pharmaceutical companies are required to
provide a Pediatric Investigation Plan (PIP) that outlines the
clinical development strategy for studying the investigational
product in the pediatric population. In some instances, a waiver
from developing a PIP for certain conditions may be granted by the
EMA when development of a medicine for use in children is not
feasible or appropriate.
EG-1962 has been granted orphan drug designation and Fast Track
designation by the U.S. Food and Drug Administration (FDA) for the
treatment of patients with subarachnoid hemorrhage (SAH). The
European Commission has granted orphan drug designation to EG-1962
for treatment of aSAH. In the U.S., products with indications
having an orphan designation, such as EG-1962 in SAH, are exempt
from requirements to assess the safety and effectiveness for the
claimed indication in a pediatric population to support a new drug
application submission.
About Edge Therapeutics, Inc.Edge Therapeutics,
Inc. is a clinical-stage biotechnology company that discovers,
develops and seeks to commercialize novel, hospital-based therapies
capable of transforming treatment paradigms for the management of
acute, life-threatening neurological and other conditions. EG-1962,
Edge’s lead product candidate, has the potential to fundamentally
improve patient outcomes and transform the management of aneurysmal
subarachnoid hemorrhage, which is bleeding around the brain due to
a ruptured brain aneurysm. Edge is evaluating EG-1962 in two
clinical studies: a pivotal Phase 3 NEWTON 2 study of EG-1962
delivered via external ventricular drain, and a study of direct
intracisternal administration of EG-1962. For additional
information about Edge, please visit www.edgetherapeutics.com.
Forward-Looking StatementsThis press release
and any statements of representatives of Edge Therapeutics, Inc.
related thereto that are not historical in nature contain, or may
contain, among other things, certain "forward-looking statements"
within the meaning of the Private Securities Litigation Reform Act
of 1995. These forward-looking statements may include, without
limitation, statements with respect to Edge’s plans, objectives,
projections, expectations and intentions and other statements
identified by words such as "projects," "may," "will," "could,"
"would," "should," "believes," "expects," "anticipates,"
"estimates," “seeks,” "intends," "plans," "potential" or similar
expressions, including statements with respect to Edge’s future
clinical plans, Edge’s ability to advance its portfolio of
therapies towards commercialization and the potential effects of
its products. These statements are based upon the current beliefs
and expectations of Edge’s management and are subject to
significant risks and uncertainties. Actual results may differ
significantly from those set forth in the forward-looking
statements. These forward-looking statements involve certain risks
and uncertainties that are subject to change based on various risk
factors (many of which are beyond Edge's control) as described
under the heading "Risk Factors" in Edge’s filings with the United
States Securities and Exchange Commission.
Investor Contact:
Gregory Gin
Edge Therapeutics, Inc.
Tel: 1-800-208-EDGE (3343)
Email: ir@edgetherapeutics.com
Media Contact:
Laura Bagby
6 Degrees
Tel: 312-448-8098
Email: lbagby@6degreespr.com
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