Genentech's "Dear Doctor" letter concerning cases of hemolytic anemia with its plaque psoriasis therapy Raptiva (efalizumab) was sent to dermatologists and nurses, the company said July 20.

The "Dear Healthcare Provider" letter, which was sent July 15, alerts physicians to a new warning on immune-mediated hemolytic anemia and revised warnings on serious infections and thrombocytopenia in labeling for Raptiva.

"Two cases of hemolytic anemia were observed in Raptiva clinical trials. Two additional cases were reported in the postmarketing setting," the letter states. "In two severe cases the hemoglobin decreased to 6 and 7 g/dL."

The letter notes that "a causal relationship between Raptiva and these events has not been established but cannot be excluded."

The letter also addresses the addition of "rare postmarketing reports of necrotizing fasciitis, tuberculous pneumonia, bacterial sepsis with seeding of distant sites, severe pneumonia with neutropenia, and worsening of infection (e.g. cellulites, pneumonia) despite antimicrobial treatment" to the existing warning on serious infections in Raptiva's label.

Raptiva labeling was updated with the new safety information June 10. Genentech previewed the letter during its July 11 second quarter earnings call (¹ Also see "Genentech Will Alert Physicians To Raptiva Anemia Warning" - Pink Sheet, 12 July, 2005.).

- Andrew Kasper

Genentech Sends Raptiva “Dear Doctor” Letter To Dermatologists, Nurses

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