Servier submits a Marketing Authorization Application to the European Medicines Agency (EMA) for TIBSOVO® (ivosidenib tablets) for patients with IDH1-mutated Acute Myeloid Leukemia (AML) and Cholangiocarcinoma

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Mar 10, 2022, 08:48 ET

- TIBSOVO is an inhibitor of the mutated isocitrate dehydrogenase-1(IDH1) enzyme

- TIBSOVO is the first IDH1 mutation specific targeted therapy submitted in Europe

- The submission covers countries of the European Union as well as Iceland, Liechtenstein and Norway

PARIS, March 10, 2022 /PRNewswire/ -- Servier, a global pharmaceutical company, today announced that it has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for TIBSOVO (ivosidenib tablets) for two indications as a first line treatment, in combination with azacitidine, in patients with previously untreated IDH1-mutated acute myeloid leukemia (AML) and not eligible for intensive chemotherapy, as well as in previously treated, locally advanced or metastatic IDH1-mutated cholangiocarcinoma. TIBSOVO is an inhibitor of the mutated isocitrate dehydrogenase-1 (IDH1) enzyme. TIBSOVO is the first IDH1 mutation specific targeted therapy to be submitted for registration in Europe.

"This MAA submission is a further step towards the availability of TIBSOVO in Europe, a targeted therapy for patients with previously untreated IDH1-mutated acute myeloid leukemia, and previously treated, locally advanced or metastatic IDH1-mutated cholangiocarcinoma – two rare cancers for which therapeutic options are limited," said Claude Bertrand, Executive Vice President R&D of the Servier Group. "We look forward to working with the EMA throughout the evaluation process of TIBSOVO, which is the first IDH1 mutation specific targeted therapy to be submitted in Europe."

"At Servier, we are committed to finding new therapeutic solutions for patients with difficult-to-treat cancers with high unmet medical needs. With this filing submission to the EMA, we hope to soon be able to make TIBSOVO available to patients with newly diagnosed IDH1-mutated AML, and to patients suffering from previously treated, locally advanced or metastatic IDH1-mutated cholangiocarcinoma," explained Dr. Philippe Gonnard, Executive Vice President Global Medical & Patient Affairs of the Servier Group.

About Servier

Servier is a global pharmaceutical Group governed by a Foundation. With a strong international presence in 150 countries and a total revenue of 4.7 billion euros in 2021, Servier employs 21,800 people worldwide. Servier is an independent Group that invests over 20% of its brand-name revenue in Research and Development every year. To accelerate therapeutic innovation for the benefit of patients, the Group is committed to open and collaborative innovation with academic partners, pharmaceutical groups, and biotech companies. It also integrates the patient's voice at the heart of its activities.

A leader in cardiology, the ambition of the Servier Group is to become a renowned and innovative player in oncology. Its growth is based on a sustained commitment to cardiovascular and metabolic diseases, oncology, neuroscience and immuno-inflammatory diseases. To promote access to healthcare for all, the Servier Group also offers a range of quality generic drugs covering most pathologies. More information: servier.com.

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