Shionogi files New Drug Application in Japan

BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that its partner, Shionogi & Co., Ltd. has filed a New Drug Application (NDA) in Japan to seek regulatory approval for intravenous (i.v.) peramivir to treat patients with influenza. As a consequence of this filing, BioCryst will receive a regulatory milestone payment of $7 million under its agreement with Shionogi.

"We congratulate Shionogi on this accomplishment and the great effort its team made to swiftly prepare the filing. This is the first application for marketing approval of peramivir in any country and it is a significant landmark for BioCryst," said Jon P. Stonehouse, President and Chief Executive Officer of BioCryst. "BioCryst continues to work with U.S. agencies, other governments and our partners to provide i.v. peramivir as a treatment option for hospitalized patients with influenza during the ongoing pandemic, and to complete the development of peramivir through the traditional regulatory pathway."

SOURCE BioCryst Pharmaceuticals, Inc.

Comments

The opinions expressed here are the views of the writer and do not necessarily reflect the views and opinions of News Medical.
Post a new comment
Post

While we only use edited and approved content for Azthena answers, it may on occasions provide incorrect responses. Please confirm any data provided with the related suppliers or authors. We do not provide medical advice, if you search for medical information you must always consult a medical professional before acting on any information provided.

Your questions, but not your email details will be shared with OpenAI and retained for 30 days in accordance with their privacy principles.

Please do not ask questions that use sensitive or confidential information.

Read the full Terms & Conditions.

You might also like...
A novel approach to photosynthetic production of high-value compounds