Monday, February 22, 2010

PEGylated pharmaceuticals on the market

PEGylated pharmaceuticals on the market
PEGylated pharmaceuticals on the market

The clinical value of PEGylation is now well established. ADAGEN (PEG- bovine adenosine deaminase) manufactured by Enzon Pharmaceuticals, Inc., US was the first PEGylated protein approved by the U.S. Food and Drug Administration (FDA) in March 1990, to enter the market. It is used to treat X-linked severe combined immunogenicity syndrome, as an alternative to bone marrow transplantation and enzyme replacement by gene therapy. Since the introduction of ADAGEN, a large number of PEGylated protein and peptide pharmaceuticals have followed and many others are under clinical trial or under development stages. Some of the successful examples are:

* PEGASYS: PEGylated interferon alpha for use in the treatment of chronic hepatitis C and hepatitis B (Hoffman-La Roche)

* Pegintron: PEGylated interferon alpha for use in the treatment of chronic hepatitis C and hepatitis B (Schering-Plough / Enzon)

* Oncaspar: PEGylated L-asparaginase for the treatment of acute lymphoblastic leukemia in patients who are hypersensitive to the native unmodified form of L-asparaginase (Enzon). This drug was recently approved for front line use.

* Neulasta: PEGylated recombinant methionyl human granulocyte colony-stimulating factor for severe cancer chemotherapy induced neutropenia (Amgen)

* Doxil/Caelyx: PEGylated liposome containing doxorubicin for the treatment of cancer (Ortho Biotech / Schering-Plough)

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