Raptiva Withdrawal Shows Comparative Safety Focus From New, Decisive FDA
Market withdrawal of Genentech's psoriasis drug Raptiva (efalizumab) shows FDA under new leadership acting decisively on drug safety - especially in cases where comparable treatment alternatives exist
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Biogen Idec noted that 100,000 patients have been treated with the drug since launch and emphasized that the only reported PML case occurred in a patient on long-term treatment despite having a known risk factor.
Biologics for psoriasis leapfrogged existing treatments in the last decade, greatly improving the standard of care. Although those may still see incremental improvements, the real changes for patient care may come with the introduction of new oral and topical treatments. START-UP profiles four emerging companies that are tackling this challenge: Avexxin, Cellceutix, Creabilis, and Convoy Therapeutics.
FDA, the European Medicines Agency and the pharmaceutical industry have embarked on a new cooperative effort to develop solutions to drug-related progressive multifocal leukoencephalopathy – a collaboration that could be a springboard for better disease/drug-specific cooperation.