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news.The FDA has accepted Lorus' proposal for a rolling submission for its new drug application for Virulizin, the company's lead anticancer drug for the treatment of pancreatic cancer.
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The agreement comes after Lorus met with the FDA on May 25, 2005 to discuss the chemistry, manufacturing, controls (quality) and non-clinical data packages that it plans to submit as part of the rolling new drug application (NDA) submission.
Products in fast track drug development programs, such as Lorus’ Virulizin, may be considered for priority review and filing of portions of an application (rolling NDA) as they become available for submission. The criteria for a rolling NDA are designed for drug candidates, such as Virulizin, which have received fast track designation, and allows for completed sections of an NDA to be submitted on an ongoing basis.
It has been a busy week for biopharmaceutical maker Lorus; as just a few days before receiving the positive indication from the FDA, the company was awarded orphan drug status for Virulizin in the EU. Further developments will now occur as developments are reached in an ongoing phase III trial, which is anticipated to yield results for scrutiny in the second half of 2005.
“Pursuing a rolling NDA is an important part of Lorus’ strategy to bring Virulizin to market for the treatment of pancreatic cancer, as quickly as possible after the conclusion of our global clinical phase III trial,” said Dr Jim Wright, CEO, Lorus.