Servier's VORANIGO® (vorasidenib) Receives Prestigious 2025 Prix Galien USA Award

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Oct 31, 2025, 08:00 ET

BOSTON, Oct. 31, 2025 /PRNewswire/ -- Servier today announced that VORANIGO^® (vorasidenib) has been awarded The Galien Foundation's 2025 Prix Galien USA Award for Best Product for Orphan/Rare Disease. The award was presented during a ceremony at the American Museum of Natural History in New York on October 30, 2025.

"We are incredibly honored to receive this prestigious award from The Galien Foundation. We take great pride in the recognition of the groundbreaking scientific achievements that brought VORANIGO to thousands of patients living with glioma in the U.S.," said David K. Lee, Executive Vice President, USA, Servier Pharmaceuticals. "This award is an endorsement of Servier's innovative approach to drug development, as well as our patient-focused and values-driven identity. We're redrawing the pharmaceutical landscape and transforming our organization into a global force in precision oncology guided by our belief that no disease is too challenging to address, and no patient population is too small to benefit."

The Prix Galien Award is the world's highest independent distinction that awards the most critical products introduced in the public market and acknowledges the achievements of the best research teams in the pharmaceutical, biotechnology, medical technology, and digital health industries. The Prix Galien is regarded as the equivalent of the Nobel Prize in biopharmaceutical research.

VORANIGO is the first and only targeted treatment approved by the U.S. Food and Drug Administration (FDA) to treat patients with Grade 2 glioma with a susceptible isocitrate dehydrogenase-1 (IDH1) or isocitrate dehydrogenase-2 (IDH2) mutation. VORANIGO was granted Fast Track, Breakthrough and Orphan Drug Designations and was approved by the U.S. FDA on August 6, 2024, under Priority Review.

Media Contact
Darby Malkin: [email protected]

About Servier in Oncology
Servier is a global leader in oncology, governed by a non-profit foundation. Servier approaches innovation with a long-term vision, free of influence from fiduciary responsibilities.

Servier is the leader in IDH-mutant targeted therapies and devotes more than 65% of its research and development budget to Oncology. Servier aspires to advance more targeted therapies by identifying mutations and understanding how these mutations impact cancer and its progression. Servier believes we can serve more people by helping the right patients find the right treatment, at the right time.

Servier takes a One Innovation Engine approach to R&D and is actively seeking alliances, partnerships and acquisitions at various stages of the portfolio.

For more information about working with Servier to bring the promise of tomorrow to the patients it serves, visit Servier.us.

About Glioma ¹
Gliomas are tumors that arise from glial or precursor cells within the central nervous system (CNS). The 2021 World Health Organization (WHO) classification recognizes four general groups of gliomas, one of which is adult-type diffuse gliomas. These diffuse gliomas are the most common primary malignant brain tumors in adults. The pathogenesis and prognosis of these tumors are tightly linked to mutations (or lack thereof) in the metabolic enzyme isocitrate dehydrogenase (IDH), and molecular testing is required for proper diagnosis.

VORANIGO IMPORTANT SAFETY INFORMATION  

What is VORANIGO? 

VORANIGO (40 mg tablets) is a prescription medicine used to treat adults and children 12 years of age and older with certain types of brain tumors called astrocytoma or oligodendroglioma with an isocitrate dehydrogenase-1 (IDH1) or isocitrate dehydrogenase-2 (IDH2) mutation, following surgery. Your healthcare provider will perform a test to make sure that VORANIGO is right for you. It is not known if VORANIGO is safe and effective in children under 12 years of age.

What are the possible side effects of VORANIGO? 

VORANIGO may cause serious side effects, including:

Liver problems. Changes in liver function blood tests may happen during treatment with VORANIGO and can be serious. Your healthcare provider will do blood tests to check your liver function before and during treatment with VORANIGO. Tell your healthcare provider right away if you develop any of the following signs and symptoms of liver problems:  
yellowing of your skin or the white part of your eyes (jaundice) 
dark tea-colored urine 
loss of appetite 
pain on the upper right side of your stomach area 
feeling very tired or weak

The most common side effects of VORANIGO include:

increased liver enzyme levels in the blood  
lack of energy, tiredness 
headache 
COVID-19 
muscle aches or stiffness 
diarrhea 
nausea 
seizure

Your healthcare provider may change your dose, temporarily stop, or permanently stop treatment with VORANIGO if you have certain side effects. 

VORANIGO may affect fertility in females and males, which may affect the ability to have children. Talk to your healthcare provider if this is a concern for you.  
These are not all of the possible side effects of VORANIGO. 

Before taking VORANIGO, tell your healthcare provider about all of your medical conditions, including if you:

have liver problems 
have kidney problems or are on dialysis 
smoke tobacco 
are pregnant or plan to become pregnant. VORANIGO can harm your unborn baby

Females who are able to become pregnant:

Your healthcare provider will do a pregnancy test before you start treatment with VORANIGO 
You should use effective nonhormonal birth control during treatment with VORANIGO and for 3 months after the last dose. VORANIGO may affect how hormonal contraceptives (birth control) work and cause them to not work well. Talk to your healthcare provider about birth control methods that may be right for you during treatment with VORANIGO 
Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with VORANIGO

Males with female partners who are able to become pregnant:

You should use effective birth control during treatment with VORANIGO and for 3 months after the last dose 
Tell your healthcare provider right away if your partner becomes pregnant or thinks she may be pregnant during your treatment with VORANIGO

Tell your healthcare provider if you are breastfeeding or plan to breastfeed. It is not known if VORANIGO passes into breast milk. Do not breastfeed during treatment with VORANIGO and for 2 months after the last dose.  

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. VORANIGO may affect the way other medicines work, and other medicines may affect how VORANIGO works. 

Please click here for full prescribing information.  

Disclosures 
This release contains general information about the Servier Group and its entities (hereinafter "Servier and its Affiliates") and is intended for informational purposes only. The information is thought to be reliable; however, Servier and its Affiliates make no representation as to the accuracy or completeness of the information contained herein or otherwise provided and accept no responsibility or liability, in contract, in tort, in negligence, or otherwise, should the information be found to be inaccurate or incomplete in any respect.

Servier and its Affiliates are not acting as an advisor to the recipient of this information, and the ultimate decision to proceed with any transaction rests solely with the recipient of this information. Therefore, prior to entering into any proposed transaction, the recipient of this information should determine, without reliance upon Servier or its Affiliates, the economic risks and merits, as well as the legal, tax, and accounting characterizations and consequences, of the transaction and that it is able to assume these risks.

This statement also contains forward-looking statements that are subject to varying levels of uncertainty and risk. Investigational new drugs and indications are subject to further scientific and medical review and regulatory approval. They are not approved for use by the FDA.

Any reliance placed on this document is done entirely at the risk of the person placing such reliance. The information contained in this document is neither an offer to sell nor the solicitation of an offer to enter into a transaction.

The content of this document is a summary only, is not complete, and does not include all material information about Servier and its Affiliates, including potential conflicts of interest.

To the maximum extent permitted by applicable laws and regulations, Servier and its Affiliates disclaim all representations, warranties, conditions and guarantees, whether express, implied, statutory or of other kind, nor does it accept any duty to any person, in connection with this document. Without prejudice to the generality of the foregoing, Servier and its Affiliates do not warrant or represent that the information or opinions contained in this document is accurate or complete.

To the maximum extent permitted by applicable laws and regulations, Servier and its Affiliates shall not be liable for any loss, damage or expense whatsoever, whether direct or indirect, howsoever arising, whether in contract, tort (including negligence), strict liability or otherwise, for direct, indirect, incidental, consequential, punitive or special damages arising out of or in connection with this document, including (without limitation) any course of action taken on the basis of the same. The estimates, strategies, and views expressed in this document are based upon past or current data and information and are subject to change without notice. 

References
1. Louis DN, Perry A, Wesseling P, Brat DJ, Cree IA, Figarella-Branger D, Hawkins C, Ng HK, Pfister SM, Reifenberger G, Soffietti R, von Deimling A, Ellison DW. The 2021 WHO Classification of Tumors of the Central Nervous System: a summary. Neuro Oncol. 2021 Aug 2;23(8):1231-1251. doi: 10.1093/neuonc/noab106. PMID: 34185076; PMCID: PMC8328013.

SOURCE Servier Pharmaceuticals