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  5. Erdafitinib Receives Regulatory Approval in U.S.

April 18, 2019

Otsuka Pharmaceutical Co., Ltd.


Erdafitinib Receives Regulatory Approval in U.S.

Otsuka Pharmaceutical Co., Ltd. ("Otsuka") announces that its Cambridge-U.K. based subsidiary Astex Pharmaceuticals (Astex) has received a milestone payment from Janssen Pharmaceutica N.V. (Janssen), following the U.S. Food and Drug Administration's (FDA) accelerated review and approval of a Janssen New Drug Application (NDA) for erdafitinib for the treatment of adults with locally advanced or metastatic urothelial carcinoma (mUC) which has susceptible fibroblast growth factor receptor (FGFR)3 or FGFR2 genetic alterations and which has progressed during or following at least one line of prior platinum-containing chemotherapy, including within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy.

Erdafitinib is a once-daily, oral pan-FGFR inhibitor that was discovered by Astex and Janssen as part of a 2008 exclusive worldwide collaboration and license agreement to identify novel, small molecule inhibitors of FGFR kinase, including for the treatment of cancer. Under the ongoing collaboration, Janssen is responsible for the clinical development and commercialization of all products, including erdafitinib. Astex is eligible to receive further milestone payments on additional regulatory filings and approvals in the U.S. and Europe and for additional indications, as well as tiered double-digit royalty payments on annual sales of erdafitinib.

Astex strives to discover new medicines for cancer patients and is proud that erdafitinib is the second of its pharma-partnered products to have been approved in the last two years.

Information in this news release was current as of the original release date.

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