FDA has accepted a BLA for bentracimab, the first and only ticagrelor reversal agent, for filing and priority review
August 02 2024 - 8:35AM
SFJ Pharmaceuticals, (SFJ), Sponsor of the bentracimab Biologics
License Application (BLA), and SERB Pharmaceuticals (SERB), who
acquired exclusive US rights to bentracimab from SFJ and will
commercialize bentracimab in the United States, announced today
that the US Food and Drug Administration (FDA) has accepted the
bentracimab BLA for filing and priority review with a target action
date in Q1 of 2025.
Bentracimab is a human monoclonal antibody fragment being
developed as a specific reversal agent for patients treated with
ticagrelor (BRILINTA®) when reversal of antiplatelet effects of
ticagrelor and its active metabolite is needed in patients
requiring nondeferrable surgery/invasive procedure or in patients
experiencing major bleeding. In 2019, bentracimab received
Breakthrough Therapy Designation from the FDA, a process designed
to expedite the development and review of drugs which may
demonstrate substantial improvement over available therapy.
Dr. Barbara White, President and CEO of SFJ, said "Bentracimab
has the potential to be an important medical advance if approved as
the first and only specific reversal agent for ticagrelor, a P2Y12
platelet inhibitor. We are confident that the data from the planned
second interim analysis will support approval of bentracimab under
priority review of the BLA."
“Urgent medical situations can arise in patients on ticagrelor
in which rapid reversal of ticagrelor’s anti-platelet effects could
reduce the risk of major bleeding or facilitate hemostasis,“ said
Deepak L. Bhatt, MD, MPH, MBA, Director of the Mount Sinai Fuster
Heart Hospital and the Dr. Valentin Fuster Professor of
Cardiovascular Medicine at the Icahn School of Medicine at Mount
Sinai and Principal Investigator on the Phase 3 REVERSE-IT study.
“Bentracimab has been shown in studies to reverse the anti-platelet
effects of ticagrelor within 5-10 minutes after the start of its
intravenous infusion.”i,ii
Vanessa Wolfeler, CEO of SERB Pharmaceuticals, said "This
milestone of BLA filing brings us closer to delivering a
breakthrough therapy for patients and marks an important step in
the next stage of growth for SERB. The approval of bentracimab
would offer US hospitals a much-needed solution to reverse the
antiplatelet effects of ticagrelor and rapidly restore platelet
function when needed.”
The BLA submission is based on the planned second interim
analysis results of the Phase 3 REVERSE-IT trial. The first interim
analysis results of the REVERSE-IT trial were published in the New
England Journal of Medicine Evidence in 2021.iii
About Ticagrelor (BRILINTA®)
Ticagrelor, marketed by AstraZeneca as BRILINTA®, is P2Y12
platelet inhibitor indicated: 1) to reduce the risk of
cardiovascular death, myocardial infarction (MI), and stroke in
patients with acute coronary syndrome (ACS) or a history of MI.
BRILINTA® also reduces the risk of stent thrombosis in patients who
have been stented for treatment of ACS; 2) to reduce the risk of a
first MI or stroke in patients with coronary artery disease at high
risk for such events; and 3) to reduce the risk of stroke in
patients with acute ischemic stroke or high-risk transient ischemic
attack.i
About SFJ Pharmaceuticals
SFJ is a global drug development company, which provides a
unique and highly customized clinical development partnering model
for the world’s top pharmaceutical and biotechnology companies. SFJ
provides at-risk funding and the global clinical development
management and oversight necessary for regulatory submission for
some of the most promising drug development programs of
pharmaceutical and biotechnology companies. SFJ’s mission is to
leverage its financial strength and global team of pharmaceutical
development experts to accelerate the development of life-saving
and life-enhancing drugs for the benefit of physicians and the
patients they serve. www.sfj-pharma.com
About SERB Pharmaceuticals
SERB is a global specialty pharmaceutical company with a growing
portfolio of medicines for emergency care and rare diseases. For
over 30 years we have made treating these complex and
life-threatening conditions possible, supporting clinicians,
healthcare systems and governments while offering hope to patients
and their families. SERB is a leading provider of essential acute
care medicines, addressing unmet medical needs and supplying
antidotes and medical countermeasures for chemical, biological,
radiological and nuclear (CBRN) risks. As a fully integrated
company, we have the experience and capabilities to acquire,
develop, and manufacture our medicines to the highest standards,
and make them available worldwide through our secure supply chain.
Learn more at https://SERB.com.
For further information contact:
SFJ Pharmaceuticals: Jonathan DeBenedetto, Chief
Financial Officerjonathan.debenedetto@sfj-pharma.com; Tel:
+1-925-223-6233
SERB Pharmaceuticals: Chris Sampson, Director of
Corporate Communications chris.sampson@serb.com; Tel: +44 (0)7773
251 178
References:
i BRILINTA® (ticagrelor) Prescribing Information
ii Bhatt DL, Pollack CV, Weitz JI, Jennings LK, Xu S, Arnold SE,
Umstead BR, Mays MC, Lee JS. Antibody-Based Ticagrelor Reversal
Agent in Healthy Volunteers. N Engl J Med. 2019 May
9;380(19):1825-1833. doi: 10.1056/NEJMoa1901778. Epub 2019 Mar 17.
PMID: 30883047.
iii Bhatt DL, Pollack CV, Mazer CD, Angiolillo DJ, Steg PG,
James SK, Weitz JI, Ramnath R, Arnold SE, Mays MC, Umstead BR,
White B, Hickey LL, Jennings LK, Curry BJ, Lee JS, Verma S.
Bentracimab for Ticagrelor Reversal in Patients Undergoing Urgent
Surgery. NEJM Evid. 2022 Mar;1(3):EVIDoa2100047. doi:
10.1056/EVIDoa2100047. Epub 2021 Dec 1. PMID: 38319214.
Chris Sampson, Director of Corporate Communications
SERB Pharmaceuticals
+44 7773 251 178
chris.sampson@serb.com
Jonathan DeBenedetto, Chief Financial Officer
SFJ Pharmaceuticals
+1-925-223-6233
jonathan.debenedetto@sfj-pharma.com