Merck takes its case for boceprevir to the FDA panel

This is Merck's big day at the FDA, as an expert panel takes a close look at the pros and cons regarding the hepatitis C drug boceprevir. Widely viewed as a likely winner at the agency, especially after an FDA team endorsed its efficacy relative to the current standard of aging treatments, Merck's own experts spent part of this morning reassuring the panel that a prime side effect--anemia--can be dealt with effectively by practitioners if it develops in patients.

"Merck's anemia argument, boiled down, is that yes, (boceprevir) exacerbates anemia but it is transient, treatable and didn't have a negative effect on efficacy," commented TheStreet's Adam Feuerstein, as he live-blogged the conversation. "Merck again making an argument for allowing response guided therapy, or shortened therapy, with (boceprevir) will reduce exposure to BOC and therefore lower adverse events, i.e improve (boceprevir) safety."

Over at Reuters, Lisa Richwine observes that Merck is highlighting the shortcomings of standard therapies, noting that current therapies only offer cures to 40 percent of patients. "There is a substantial unmet medical need for new therapies to treat chronic hepatitis C infection," said Merck's Dr. Laurie MacDonald.

The crucial vote on the drug's risk-benefit profile comes later this afternoon, after more discussion on the efficacy and safety of the drug. Interestingly, as Merck sought to persuade the experts on boceprevir, Vertex ($VRTX) saw its shares rising again this morning. Vertex will take its place in front of the same panel tomorrow, as its investigators make a case for telaprevir. Analysts give both therapies a solid shot at an approval, as physicians appear eager to shift to a new standard of care.

- read the Reuters story
- here's the link to Feuerstein's live blog