Navidea Biopharmaceuticals ($NAVB) is still licking its wounds after the FDA rejected its application to get Lymphoseek approved in the U.S. But now the company is taking its cancer diagnostic tool to the European Medicines Agency, seeking marketing approval overseas.
September's regulatory blow tanked Navidea's shares, but there's something of a silver lining: The FDA's rejection was based on the manufacturing practices of a third-party contractor, Navidea said, and the company re-applied for U.S. approval at the end of October with a goal approval date of April 30.
Now, as it looks to get Lymphoseek on shelves in Europe, Navidea says it has solved the manufacturing ills that torpedoed its FDA app.
"It is also important to note that, as part of the normal (application) filing process, the EMA required good manufacturing practices pre-submission inspections at the Lymphoseek contract manufacturing facilities," CEO Mark Pykett said in a statement. "These inspections were recently successfully completed by independent auditors from the European Union, thereby enabling our MAA filing."
Lymphoseek is designed to bind to the lymph nodes, finding those that drain from a primary tumor in patients with breast cancer or melanoma. Then, in an imaging procedure called lymphatic mapping, physicians can see if the cancer has spread, guiding biopsies and therapy decisions.
- read Navidea's release