Sunday, March 11, 2007
Article in the New York Times -- Drug Maker Stops Work on Lung Disease Medicine, by Andrew Pollack. Here's an excerpt:
Desperate patients with a potentially fatal lung condition have spent hundreds of millions of dollars over the last few years on a drug that was not approved for their disease but was promoted for that use by its manufacturer.
Now it appears the drug does not work after all.
The drug’s maker, InterMune, said yesterday that it was abandoning efforts to develop the product, Actimmune, as a treatment for idiopathic pulmonary fibrosis because results from a late-stage clinical trial showed the drug did not prolong lives. The drug is already federally approved to treat two other rare conditions.
The company said the 826-patient trial was being stopped after an interim analysis showed that 14.5 percent of the patients getting Actimmune had already died, compared with 12.7 percent of those getting a placebo. Statistically speaking, there was no meaningful difference in survival between the two groups.
The failure will be considered a blow to the 80,000 or more Americans with idiopathic pulmonary fibrosis, an often fatal scarring of the lungs for which there are no approved medications.
Last fall InterMune agreed to pay $36.9 million in a settlement with the federal government over allegations that it had promoted off-label use of Actimmune, which costs about $50,000 per year.