EUSA Pharma submitted its Erwinase BLA on a rolling basis, following receipt of Fast Track designation from the FDA.
EUSA Pharma’s completed BLA submission requests Priority Review status, which can reduce the regulatory assessment period to six months for major treatment advances.
Additionally, the FDA has awarded Erwinase orphan drug designation, which provides a seven-year period of market exclusivity upon approval.
EUSA Pharma chief medical officer Tim Corn said that the submission of their Erwinase BLA is a major step towards their goal of making this important therapy available as rapidly as possible.
"Many children with acute lymphoblastic leukemia develop allergy to current asparaginase products, and Erwinase provides a key therapeutic alternative for this gravely ill group in several countries," Corn said.
"By applying for Priority Review status, we hope to shorten the period before EUSA can launch Erwinase in the US, and reduce the time before physicians can provide this drug to those who may benefit from it."
EUSA Pharma president and CEO Bryan Morton said that completing the BLA filing for Erwinase marks a major strategic milestone for EUSA.
"Based on new study results and existing clinical experience, we believe Erwinase has the potential to enhance the treatment of acute lymphoblastic leukemia significantly, both in the US and further afield," Morton said.
"In the coming months, EUSA plans to achieve pan-European authorisation for Erwinase, and our partners are pursuing regulatory approval in Japan and elsewhere."