This morning, Johnson & Johnson, in partnership with Vertex, announced that FDA consented to Vertex's trial design for medicating a second set of patients (these being that are not Hep-C treatment naive) in its ongoing Phase III trials. . . . Quoth Reuters:
. . . .Vertex reiterated that it is on track with its previously stated plan of filing for approval of the drug in the second half of 2010 based on data from a Phase III, or late-stage, clinical trial of the drug in patients who have not previously been treated.
Zachry Barber, a spokesman for Vertex, said the company has not provided a timeline for completing its latest trial, called Realize, but said it expects to complete enrollment of 650 patients with the most common form of the liver-destroying disease in the first quarter of next year.The trial will be conducted in the United States and Europe and compare two 48-week telaprevir-based regimens with a 48-week control arm. . . .
This puts Schering's boceprivir even further behind the 8-ball. . . . More background on this horse-race here.
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