Monday, May 16, 2011

The Merck Hepatitis C Med: What The Wags Say

The Merck Hepatitis C Med: What The Wags Say

Over at pharmalot columnist Ed Silverman pointed out boceprevirs labeling turned out to be not as restrictive as some forecasted. At the advisory meeting on boceprevir back in April analyst Geoffrey Porges had this to say;

"If the FDA listened today and yesterday, telaprevir is going to get a broad label with simple dosing and boceprevir is going to get a label with some limitations,"

Also noted in the pharmalot article ;

There is no Risk Evaluation and Mitigation Strategy, or REMS, for instance. And Sanford Bernstein analyst Tim Anderson notes the FDA press release lists anemia alongside other side effects such as fatigue, headache and nausea, rather than a more prominent mention. The approval, he adds, allows Victrelis to be used with both Merck’s own PEG-intron or Roche’s Pegasys, even though the new Merck med was not studied in combination with Pegasys during Phase III trials. 
“The agency was generous, in our opinion, in allowing label claims for Victrelis that had not been studied in the Phase III including combination with a different interferon (Pegasys), less frequent HCV monitoring, and flexibility with treating null responders,” or those patients who have not previously responded to treatment, writes Leerink Swann analyst Howard Liang in an investor note
.Do go read the entire article

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