SOUTHBOROUGH, Mass.–(BUSINESS WIRE)–
The First Targeted Therapy for Adult Patients with Relapsed/Refractory Acute Myeloid Leukemia and an IDH1 Mutation
Veristat, 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 therapies account for more than 45% and rare disease 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.”
Veristat is a clinical research partner focused on supporting biopharmaceutical firms as they advance their therapies through the clinical development and regulatory submission 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 www.veristat.com.
TIBSOVO® is a registered trademark of Agios.
Gillian Dellacioppa, 508-306-6336