Market Overview

Veristat Congratulates Agios Pharmaceuticals on the FDA Approval of TIBSOVO®


The First Targeted Therapy for Adult Patients with
Relapsed/Refractory Acute Myeloid Leukemia and an IDH1 Mutation

a full service Clinical Research Organization (CRO), congratulates Agios
on the recent FDA approval of TIBSOVO®
(ivosidenib) for the treatment of adult patients with relapsed or
refractory acute myeloid leukemia (R/R AML) with a susceptible
isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA
approved test. TIBSOVO®, an oral, targeted inhibitor of the IDH1 enzyme,
is the first and only FDA-approved therapy for patients with R/R AML and
an IDH1 mutation.

Veristat is honored to have supported Agios with the preparation of the
New Drug Application (NDA) for ivosidenib. We congratulate Agios on the
approval of this ground-breaking therapy for patients with this
life-threatening malignancy. Veristat began working with Agios on this
compound five years ago, providing statistical and medical writing
support for their phase I study for ivosidenib which led to the recent
approval. Veristat's support continued through the preparation of the
NDA submission.

"Over the last five years, I have personally had the privilege to work
with a dedicated Agios team on the Investigational New Drug (IND)
application, phase I study, and NDA submission for ivosidenib," said
Barbara Balser, VMD, Executive Vice President and Chief Scientific
Officer at Veristat. "I am thrilled to see TIBSOVO® receive FDA approval
and look forward to seeing this therapy help improve the lives of
patients with R/R AML."

Veristat's specialization in preparing oncology and rare disease
regulatory submissions, as well as its experience with the FDA, uniquely
positioned Veristat to support Agios with this program. Cancer
account for more than 45% and rare
indications over 55% of the regulatory submission projects
that Veristat has worked on.

"On behalf of the entire Veristat team, I applaud Agios for their focus
on advancing this program to quickly bring this novel treatment to
cancer patients with no other options," stated Patrick Flanagan, Chief
Executive Officer at Veristat. "Our teams worked tirelessly to support
Agios leading up to this approval and remain committed to assist Agios
as they look to expand this compound into new indications and bring
additional compounds into early phase trials."

About Veristat:

is a clinical research partner focused on supporting biopharmaceutical
firms as they advance their therapies through the clinical
and regulatory
process. Our work delivers meaningful clinical impact and
our regulatory submission expertise is unrivaled in our industry.
Veristat teams have worked on over 70 regulatory submission projects
that have resulted in more than 40 submission approvals to date from
various regulatory agencies around the world. Over the last 5 years
alone, nearly 8% of new molecular entities (NMEs) approved by the FDA
were supported by Veristat teams. Veristat aims is to propel even the
most complex submissions to successful regulatory conclusions so that
new therapies become available to improve and save lives. For more
information, visit

TIBSOVO® is a registered trademark of Agios.

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