Pharmaceutical Company Plans Viracept Giveaway
NEW YORK (AP) _ Agouron Pharmaceuticals Inc. said today it will give away its experimental AIDS drug, Viracept, to people in an advanced stage of the disease who have exhausted other treatments.
Viracept is a member of a family of protease-inhibitor drugs that when used in combination with other drugs, can make the virus undetectable in the blood of some patients.
It will be offered to people who have stopped using three commercially available protease inhibitors because of adverse reactions, intolerable side effects or because they haven’t worked, the La Jolla, Calif.-based Agouron said.
The drug hasn’t been approved by the U.S. Food and Drug Administration. But the ``expanded access program″ announced today is an effort by the FDA to make experimental drugs available ``at the earliest opportunity to people for whom no other comparable or satisfactory therapy exists,″ the company said in a statement.
Agouron said the safety of the drug has been tested on more than 500 people and that the most commonly reported side effects were diarrhea, headache and fatigue. More tests are being conducted and Agouron said it expects to seek approval for the drug from the FDA early next year.
The company also said it will begin an expanded access program in Europe later this year.
Peter Johnson, president and chief executive officer of the San Diego-based company, estimated that ``somewhere between several hundred to probably several thousand patients″ would be candidates to receive Viracept free of charge, The Wall Street Journal reported today.
An expanded access program ends once the drug is approved for sale, but Agouron said patients in the program won’t be cut off if they lack the funds or insurance to pay for the drug, the newspaper reported.
``People like it, they don’t feel bad on it, and it seems to have good (antiviral) activity,″ Robert Schooley, head of the infectious-disease division at the University of Colorado, told the Journal.