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news.Canada-based Revive Therapeutics has submitted a pre-investigational new drug (pre-IND) package to the US Food and Drug Administration (FDA) for its gout drug candidate, REV-002.
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The submitted pre-IND package provides the US FDA with information on the company’s REV-002, as well as a clinical trial plan for a proposed US clinical trial.
The FDA’s response to the pre-IND package will serve as a guide to the company’s preparation of a full IND application.
The pre-IND submission follows the company’s recently announced meeting request letter submitted to the FDA and its announcement that it has signed a material transfer agreement (the MTA) with a global pharmaceutical company headquartered in Osaka, Japan.
The MTA has allowed the company to secure access to confidential information and clinical trial supply of REV-002 for a US-based trial.
Revive Therapeutics chief executive officer Fabio Chianelli said, "I am very pleased with this accomplishment as it paves the way for Revive’s second product scheduled for a human clinical trial and its first product for a human clinical trial in the US, the largest market for gout related products."