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FDA Grants Priority Review for Schering-Plough's Peginterferon Alfa-2b for the Adjuvant Treatment of Patients With Stage III Melanoma
Date:1/31/2008

e mild (44%) or moderate (4%) and no patient discontinued, and included injection site inflammation and reaction (ie, bruise, itchiness, irritation). Injection site pain was reported in 2% of patients receiving PEGINTRON(TM). Alopecia (thinning of the hair) is also often associated with alpha interferons including PEGINTRON(TM).

Psychiatric adverse events, which include insomnia, were common (57%) with PEGINTRON(TM) but similar to INTRON(R) A (58%). Depression was most common at 29%. Suicidal behavior including ideation, suicidal attempts, and completed suicides occurred in 1% of patients during or shortly after completing treatment with PEGINTRON(TM).

The following serious or clinically significant adverse events have been reported at a frequency less than or equal to 1% with PEGINTRON(TM) or interferon alpha: Severe decreases in neutrophil or platelet counts, hypothyroidism, hyperglycemia, hypotension, arrhythmia, ulcerative and hemorrhagic colitis, development or exacerbation of autoimmune disorders including thyroiditis, RA, systemic lupus erythematosus, psoriasis, pulmonary disorders (dyspnea, pulmonary infiltrates, pneumonitis and pneumonia, some resulting in patient deaths), urticaria, angioedema, bronchoconstriction, anaphylaxis, retinal hemorrhages, and cotton wool spots.

Additional Safety Information

Relapse of drug addiction/overdose has occurred in patients on PEGINTRON(TM) therapy. Aggressive behavior sometimes directed towards others has occurred in patients with and without a previous psychiatric disorder during PEGINTRON(TM) and/or INTRON(R) A treatment and follow-up.

If patients develop psychiatric problems, including clinical depression, it is recommended that patients be carefully monitored during treatment and in the 6-month follow-up period. If psychiatric symptoms persist or worsen, or suicidal ideation or aggressive behavior towards others is identified, it is recommended that treatment with PEGINTRON(TM) and
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SOURCE Schering-Plough Corporation
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