GAITHERSBURG, Md., April 18, 2011 /PRNewswire/ — Sigma-Tau
Pharmaceuticals, Inc. is pleased to announce that it has received
approval from the U.S. Food and Drug Administration (FDA) to
manufacture L-asparaginase, the primary ingredient in the oncology
medicine ONCASPAR® (pegaspargase). ONCASPAR is the only
FDA-approved PEGylated formulation of L-asparaginase which is a key
component in the treatment of acute lymphoblastic leukemia (ALL).
The attempt to secure approval to manufacture L-asparaginase came
after the previous supplier decided to cease production, leading to
a three-year development effort to create a comparable active
ingredient. The approval averts a potentially dangerous drug
shortage situation in the U.S. which could have affected thousands
of patients with ALL.
“To get a complex biologic medicine such as this exactly right
takes a great deal of work for both the manufacturer and the FDA,”
said Gregg Lapointe, Chief Executive Officer, Sigma-Tau
Pharmaceuticals, Inc. “We are pleased to announce that with
this approval, there will be no interruption in either the
production of the medicine or in the treatment of patients with
ALL.”
L-asparaginase is an enzyme that depletes the amino acid
asparagine, which certain leukemic cells are dependent upon for
survival. L-asparaginase was first approved in 1978 as a
treatment for ALL. In 1994, the FDA approved the PEGylated
formulation of the medicine (ONCASAPR) which has the unique
therapeutic advantages of sustained duration and prolonged effect
over the native L-asparaginase, resulting in enhanced convenience
for patients and providers. ONCASPAR is given to patients
with ALL as part of a multi-agent chemotherapeutic treatment
regimen. Administering L-asparaginase results in the
depletion of asparagine circulating in the blood, which starves the
leukemic cells and results in their death. ONCASPAR was
updated to first-line indication in 2006.
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