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Monday, 11/19/2012 2:40:22 PM

Monday, November 19, 2012 2:40:22 PM

Post# of 188
Ligand Pharma follow-up: FDA approves new indication for PROMACTA (LGND is halted) (LGND) 16.67 : GSK announced today that the FDA has approved PROMACTA for the treatment of thrombocytopenia (low blood platelet counts) in patients with chronic hepatitis C to allow them to initiate and maintain interferon-based therapy. PROMACTA is the first supportive care treatment available to patients who are ineligible or poor candidates for interferon-based therapy due to their low blood platelet counts. There are limitations to the use of PROMACTA in patients suffering from chronic hepatitis C-associated thrombocytopenia. These include:

PROMACTA should not be used in an attempt to normalize platelet counts;
PROMACTA should be used only in patients with chronic hepatitis C whose degree of thrombocytopenia prevents the initiation of interferon therapy or limits the ability to maintain optimal interferon-based therapy;
Safety and efficacy have not been established in combination with direct-acting antiviral agents approved for treatment of chronic hepatitis C genotype 1 infection.