To almost no one's surprise the FDA announced on Friday that it had stamped Merck's boceprevir--to be sold as Victrelis--with an approval, setting the stage for a more-than-likely approval of telaprevir by the FDA's May 23rd PDUFA date. And the pair of treatments is expected to help usher in a new generation of cocktail therapies for millions of patients threatened by hepatitis C.
The approval for boceprevir came without any of the regulatory strings that some analysts had fretted over. There was no requirement on REMS and no temporary delays as some analysts had predicted. And that open path will encourage other developers advancing their own programs. More hepatitis C drugs are in the pipelines of Roche, Pharmasset and Bristol-Myers Squibb to further advance the standard of care, promising to wipe out the virus earlier with fewer side effects.
"What we're working toward is getting new drugs that attack the virus in different places and then we're going to combine those drugs,'' Eliav Barr, Merck's vice president of infectious disease, told the Star-Ledger.
The stakes are huge, which is a big motivator for Merck, Vertex and others now developing treatments. Forbes' Matthew Herper notes that Goldman Sachs expects these drugs to help drive spending on hep C drugs from $3 billion to $10 billion.
"I think we've set a really high bar,'' Camilla Graham, vice president of global medical affairs at Vertex, told the Star-Ledger. "We're looking for high cure rates for as short a treatment period as possible. To be able to shorten the treatment period to 24 weeks is a big step forward."