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European Medicines Agency’s accepts MAA for infigratinib for patients with cholangiocarcinoma with fibroblast growth factor receptor 2 fusions or rearrangement. Helsinn + BridgeBio Pharma.

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Published:3rd Jan 2022
Helsinn Group a fully integrated, global biopharma company with a diversified pipeline of innovative oncology assets and strong track-record of commercial execution, announced that the European Medicines Agency (EMA) accepted for review the Company’s Marketing Authorization Application (MAA) for infigratinib for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement.

The EMA’s acceptance for review of the MAA confirms that the submission is complete and the formal review process can begin. In March 2021, Helsinn Group entered a strategic collaboration with QED Therapeutics, an affiliate company of BridgeBio Pharma, Inc., a commercial-stage biopharmaceutical company focused on genetic diseases and cancers, to co-develop and co-commercialize infigratinib in oncology indications worldwide except in China, Hong Kong and Macau.

Condition: Cholangiocarcinoma
Type: drug

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