Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Sigma-Tau Pharmaceuticals, a developer and commercializer of medicines for patients with rare diseases, has received the US Food and Drug Administration's (FDA) approval for the manufacturing of L-asparaginase, a primary ingredient of oncology medicine Oncaspar (pegaspargase).
Subscribe to our email newsletter
L-asparaginase, a key component in the treatment of acute lymphoblastic leukemia (ALL), is an enzyme that depletes the amino acid asparagine, which certain leukemic cells are dependent upon for survival.
Oncaspar allows patients to gain the full benefits of asparaginase therapy with enhanced patient convenience over native L-asparaginase (nonPEGylated form).
Through the process of pegylation, the half-life of L-asparaginase is significantly increased and the L-asparaginase activity is sustained.
The 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.
Sigma-Tau said the approval averts a potentially dangerous drug shortage situation in the US which could have affected thousands of patients with ALL.