Sigma Tau Pharma Ltd. (hereinafter referred to as Sigma-Tau Rare Disease), today announced the submission of an application to the European Medicines Agency (EMA) for use of its pegylatedL-asparaginase, Oncaspar® (pegaspargase) for the treatment of Acute Lymphoblastic Leukaemia (ALL) as part of a multi-agent chemotherapeutic regimen.
The submission is based on extensive clinical data generated from a sponsored clinical development program and independent investigator-initiated trials, carried on both in Europe and the United States.
Dr. Marco Brughera, Global Head of Sigma-Tau Rare Disease, commenting on the submission states, "This filing represents an important cornerstone of the continuous growth of our onco-haematology portfolio. It reinforces Sigma-Tau Rare Disease's commitment to patient care and our efforts to improve access and expand Oncaspar's clinical profile."
The drug is already approved in several countries including the United States, Germany, Poland, Russia, and Argentina.
With the submission to the EMA, Sigma-Tau Rare Disease aims at making the product equally available in all European Union states.
Sigma-Tau Rare Disease is dedicated to facilitating access and improving quality of care for ALL patients.