Omeros Corporation Receives Interim Response from FDA on Formal Dispute Resolution Request for Narsoplimab
August 17 2022 - 08:40AM
Business Wire
Omeros Corporation (Nasdaq: OMER) today announced that the
United States Food and Drug Administration (FDA) provided an
interim response to the company’s formal dispute resolution request
submitted to the Agency in June, appealing the earlier decision by
the FDA review division to issue a complete response letter for the
biologics license application (BLA) for narsoplimab in the
treatment of hematopoietic stem cell transplant-associated
thrombotic microangiopathy (HSCT-TMA). Formal dispute resolution is
an official pathway that enables a sponsor to appeal a decision by
an FDA division to a higher authority within the Agency, in this
case the Office of New Drugs (OND). As part of FDA’s standard
procedures for dispute resolution, Omeros and OND met last month to
discuss the appeal. Per FDA guidelines for formal dispute
resolution, a final decision from OND was to be rendered within 30
calendar days of the meeting unless the deciding official in OND
required additional information. According to FDA’s interim
response, the deciding official is collecting additional
information, and a response to Omeros’ appeal will be provided
within 30 days from the date that the additional information is
collected and any required follow-up is conducted by the deciding
official.
There is no approved treatment for HSCT-TMA. The first drug
candidate submitted to FDA for approval in HSCT-TMA, narsoplimab
has Breakthrough Therapy and Orphan-Drug designations in this
disorder as well as in IgA nephropathy.
About Omeros Corporation
Omeros is an innovative biopharmaceutical company committed to
discovering, developing and commercializing small-molecule and
protein therapeutics for large-market and orphan indications
targeting immunologic disorders including complement-mediated
diseases, cancers, and addictive and compulsive disorders. Omeros’
lead MASP-2 inhibitor narsoplimab targets the lectin pathway of
complement and is the subject of a biologics license application
pending before FDA for the treatment of hematopoietic stem cell
transplant-associated thrombotic microangiopathy (HSCT-TMA).
Narsoplimab is also in multiple late-stage clinical development
programs focused on other complement-mediated disorders, including
IgA nephropathy, COVID-19, and atypical hemolytic uremic syndrome.
OMS906, Omeros’ inhibitor of MASP-3, the key activator of the
alternative pathway of complement, is advancing in clinical
programs for paroxysmal nocturnal hemoglobinuria (PNH), complement
3 (C3) glomerulopathy and one or more related indications. For more
information about Omeros and its programs, visit
www.omeros.com.
Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of Section 27A of the Securities Act of 1933 and
Section 21E of the Securities Exchange Act of 1934, which are
subject to the “safe harbor” created by those sections for such
statements. All statements other than statements of historical fact
are forward-looking statements, which are often indicated by terms
such as “anticipate,” “believe,” “could,” “estimate,” “expect,”
“goal,” “intend,” “likely,” “look forward to,” “may,” “objective,”
“plan,” “potential,” “predict,” “project,” “should,” “slate,”
“target,” “will,” “would” and similar expressions and variations
thereof. Forward-looking statements, including expectations with
regard to Omeros’ pursuit of regulatory approval for narsoplimab in
HSCT-TMA, including expectations regarding the timing and potential
or anticipated outcomes of its formal dispute resolution request
are based on management’s beliefs and assumptions and on
information available to management only as of the date of this
press release. Omeros’ actual results could differ materially from
those anticipated in these forward-looking statements for many
reasons, including, without limitation, unanticipated or unexpected
outcomes of regulatory processes in relevant jurisdictions,
unproven preclinical and clinical development activities, changes
in our financial condition and results of operations, challenges
associated with manufacture or supply of our investigational drug
candidates, intellectual property claims, competitive developments,
litigation, and the risks, uncertainties and other factors
described under the heading “Risk Factors” in the company’s Annual
Report on Form 10-K filed with the Securities and Exchange
Commission on March 1, 2022. Given these risks, uncertainties and
other factors, you should not place undue reliance on these
forward-looking statements, and the company assumes no obligation
to update these forward-looking statements, whether as a result of
new information, future events or otherwise, except as required by
applicable law.
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version on businesswire.com: https://www.businesswire.com/news/home/20220817005274/en/
Jennifer Cook Williams Cook Williams Communications, Inc.
Investor and Media Relations IR@omeros.com
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