EUSA Pharma, a transatlantic specialty pharmaceutical company focused on oncology, oncology supportive care and critical care, announced that its Biologics License Application (BLA) for Erwinaze (L-asparaginase derived from Erwinia chrysanthemi) has been accepted for filing and awarded Priority Review status by the US Food and Drug Administration (FDA). Additionally, the FDA has previously awarded Erwinaze orphan drug designation, which provides a seven-year period of market exclusivity upon approval.
EUSA Pharma completed the rolling submission of its Erwinaze BLA on 1 November 2010, after receiving Fast Track designation from the FDA. Priority Review reduces the target regulatory assessment period to six months from the date of submission. EUSA Pharma is seeking marketing approval for Erwinaze for use in the treatment of acute lymphoblastic leukaemia in patients with hypersensitivity to E. coli-derived asparaginase. The product is currently approved in a number of countries, including Canada, the UK and several European Union member states, and is supplied in the United States under a treatment IND.
Dr Tim Corn, EUSA Pharma's chief medical officer, commented, "The award of Priority Review status for Erwinaze is another important step towards making this potentially life-saving therapy available as quickly as possible. We believe that Erwinaze has the potential to enhance the treatment of acute lymphoblastic leukaemia greatly, and hope that the ongoing Priority Review will shorten the period before US oncologists can offer this key therapeutic alternative to their patients."
Acute lymphoblastic leukaemia is the most commonly diagnosed childhood cancer . Treatment is complex, involving a number of stages and many drugs, and includes asparaginase as an essential component of current protocols. Paediatric treatment is often highly successful, with remission rates of over 95% and 75-85% of treated children surviving for at least five years without recurrence of leukaemia.
Erwinaze is an asparaginase enzyme that depletes the level of asparagine in the bloodstream. Asparagine is essential for cell growth, and its removal from the blood inhibits the growth of cells associated with acute lymphoblastic leukaemia. Asparaginase products are derived from bacteria, and up to 60% of patients develop antibodies to those produced by Escherichia coli. Erwinaze, which is produced by Erwinia chrysanthemi, is immunologically distinct from these therapies and is suitable for patients with hypersensitivity to E. coli-derived treatments.
EUSA Pharma is a rapidly growing transatlantic specialty pharmaceutical company focused on oncology, oncology supportive care and critical care products. The company has an established commercial infrastructure in the US, a pan-European presence and a wider distribution network in numerous additional territories.