Genentech on Wednesday announced the phased voluntary withdrawal of psoriasis drug Raptiva (efalizumab) from the US market "based on the association of [the drug] with an increased risk of progressive multifocal leukoencephalopathy (PML)." Hal Barron, Genentech's chief medical officer, stated that "although we believe that many psoriasis patients are benefiting from Raptiva, the balance between benefit and risk in the psoriasis population for which Raptiva was approved has significantly changed."
The company is instructing physicians to cease prescribing the drug for new patients, and to "promptly contact" those currently receiving the drug in order to consider alternative treatment options. Raptiva will no longer be available after June 8, the company said. To date, three cases of diagnosed PML have been reported in patients receiving Raptiva and one patient treated with the drug who developed progressive neurologic symptoms died of unknown causes.
The withdrawal comes after consultation with the FDA, Genentech noted, adding that the company is collaborating with Merck KGaA, its licensee outside the US and Japan, to inform regulatory authorities outside of the US of its decision. In February, the European Medicines Agency recommended that marketing authorisation for Raptiva be suspended, saying the benefits of the drug "no longer outweigh its risks."
2 comments:
I was discussing this with my students tonight - what options are there for patients if the PML risk turns out to be a class effect?
Is there any point at which people would be permitted to choose to take such medications? What level of informed consent would be required?
Too many drugs have come to market bearing pedigrees which imply that they've been clinically tested, through peer review, and through rigorous FDA evaluation. And then after millions of patients take the drug, it proves dangerous or even deadly. Bummer!
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