Back grey_arrow_rt.gif
 
 
Fed panel OKs Vertex & Merck drug
 
 
  Reported by Jules Levin
 
Bloomberg: Combined worldwide revenue from both drugs may reach $6 billion to $7 billion within three years,...... While sales in Europe will probably be "an even split," telaprevir is poised to capture 70 percent to 80 percent of a U.S. market that may surpass $4 billion......Both medicines are likely to win FDA approval and may reach the market in May or June.
 
The approvals would usher in a new generation of HCV treatments (see 'New drug targets raise hopes for hepatitis C cure'). Pharmaceutical companies are racing to bring targeted HCV therapies to market. The need is high: about 3% of the world is infected, yet the current therapy benefits only about half of patients.
 
Dow Jones: The vote amounts to a recommendation that the agency approve telaprevir. The FDA usually follows the advice of its advisory panels but isn't required to."........"We are excited by today's unanimous vote to recommend FDA approval of telaprevir, as people with hepatitis C urgently need more effective medicines," said Camilla Graham, the vice president of global medical affairs at Vertex......Vertex said rashes was managed in most patients with antihistamines and topical corticosteriods. The company said the significantly higher effectiveness of telaprevir. "In all subject categories has the potential to offer many more patients the benefits of eradicating [hepatitis C] and achieving a viral cure," the company said........The approval of the drugs, which could come in May, would pit Cambridge, Mass., Vertex against Merck, one of the world's biggest drug makers, in a market that could triple to $12 billion after the introduction of the latest batch of drugs, according to Goldman Sachs.
 
Boston Globe: Apr 29: "I think this is a long-awaited landmark day for patients with hepatitis C," said committee member Barbara H. McGovern, associate professor of medicine at Tufts University School of Medicine in Boston.......Citing telaprevir's markedly improved cure rate compared to those of current hepatitis C treatments, another committee member, Dr. Lawrence S. Friedman, chairman of the department of medicine at Newton-Wellesley Hospital, said, "It's a stunning achievement that we will be able to cure nearly 80 percent of [first-time] patients and nearly as many relapsers.".....
 
Meeting on 27 April, FDA advisers heaped praise on boceprevir which, like telaprevir, inhibits a critical HCV protein called a protease. One panel member said that to leap from 50% efficacy with standard therapy to an efficacy of about 70% with boceprevir "seems like a dream come true".
 
But advisers were also cautious about the drug's possible side-effects, particularly the risk of anaemia, and noted the need to educate physicians about those effects and how to treat them. "You need to be somewhat of a Talmudic scholar to prescribe this drug," said Lawrence Friedman of the Massachusetts General Hospital in Boston. Several panelists also noted that the drug should be approved only for those infected with one of the eleven HCV genotypes, HCV genotype 1.
 
 
 
 
  icon paper stack View Older Articles   Back to Top   www.natap.org