PEGINTRON(R) Receives A Recommendation For Approval From FDA Advisory Committee For A New Application In Melanoma

Main Category: Melanoma / Skin Cancer
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 06 Oct 2009 - 18:00 PDT

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Enzon Pharmaceuticals, Inc. (Nasdaq: ENZN) announced that the FDA Oncologic Drug Advisory Committee voted in favor of recommending approval of PEGINTRON® as a treatment in addition to surgery in patients with metastatic melanoma. The product is currently being marketed, manufactured and developed by Schering-Plough. PEGINTRON (Peginterferon alfa-2b) is currently indicated for treatment of chronic hepatitis C in patients 18 years of age or older with compensated liver disease and previously untreated with interferon alpha. PEGINTRON is also indicated for use in combination with REBETOL® (ribavirin) for the treatment of chronic hepatitis C in patients 3 years of age and older with compensated liver disease. PEGINTRON is one of several products which utilize Enzon's PEGylation technology, including CIMZIA®, Macugen®, and Pegasys®.

"We congratulate Schering-Plough for this great achievement. PEGINTRON provides effective treatment to hepatitis C patients and we are pleased Schering-Plough continues to explore its use in additional areas," said Jeffrey H. Buchalter, Enzon's president and chief executive officer.

Source
Enzon Pharmaceuticals, Inc.