Labelling for efalizumab (Raptiva) should require monitoring of platelet counts to minimise the risk of thrombocytopenia, the US FDA's Dermatologic & Ophthalmic Drugs Advisory Committee has recommended, reports The Pink Sheet. Although the Committee agreed that the overall risk-benefit ratio of efalizumab for the treatment of psoriasis is favourable, members noted that data suggest an association between the agent and the development of clinically significant thrombocytopenia, and that there are reservations regarding the lack of long-term safety data available, particularly for the detection of cancers and serious infections. In clinical trials, 8 of 2762 (0.3%) efalizumab recipients experienced platelet counts of less than 50 000/mm, five of whom were hospitalised with thrombocytopenia. In addition, 7 of 1620 (0.4%) efalizumab-treated patients were diagnosed with serious infections after first exposure to the agent, and 20 (of 1784 subject-years) developed non-melanomatous skin cancer. Genentech is to discuss the potential labelling implications for efalizumab with the FDA.
FDC Reports - The Pink Sheet - Prescription Pharmaceuticals and Biotechnology 65: 27-28, No. 38, 22 September 2003.