Vertex execs spent a good deal of this morning's FDA panel review on the hepatitis C drug telaprevir addressing one of the key safety concerns that regulators have with the drug. Tackling the rash triggered in some patients head on, the developer emphasized that only a relative handful of cases were discovered during the trial process and the patients could be quickly switched to the standard of care.
Telaprevir "produces substantial clinical benefit compared to the current treatment," Vertex Chief Medical Officer Robert Kauffman told the panel, according to a report from Reuters. There's not likely to be much argument on that point, however, and barring a nasty surprise even the safety issues aren't likely to derail telaprevir at this point.
"Rash rates (were) higher in Phase III program but discontinuation due to rash was low," messaged TheStreet's Adam Feuerstein this morning as he live-blogged the Vertex defense. And most of the cases of rash were mild to moderate, he added. Feuerstein as well as Reuters highlighted Vertex's remark that it is already gathering data on a twice-daily dosage of telaprevir, which could improve compliance compared to the thrice-daily program that the Boston biotech wants to win an endorsement on today.
There's intense interest in today's vote, which follows a unanimous recommendation for Merck's competing hepatitis C drug boceprevir. FDA regulators indicated in their staff review that telaprevir's cure rate in one trial hit 79 percent, even higher than Vertex investigators had reported. And while they appeared concerned about the rash and anemia triggered in some patients, regulators have also expressed a keen interest in seeing a new standard of care introduced for hepatitis C patients, who frequently can't continue on the current standard of care that is available.
- here's a link to Feuerstein's live blog
- here's the report from Reuters