FDA Approves Viral Hepatitis Medication; Sales of New Drug May Generate $200 Million Annually for Gilead Sciences
The Food and Drug Administration last night approved a long- awaited drug for a form of viral hepatitis, expanding treatment options for a disease that afflicts more than 1 million Americans.</br></br>The action was a significant boost for Gilead Sciences Inc., a Foster City, Calif., biotechnology company that has built a strong portfolio of antiviral drugs. Gilead already sells one of the country's fastest-growing AIDS treatments, and analysts have said the new hepatitis B drug, known as Hepsera or adefovir dipivoxil, could bring revenue of $200 million a year or more.</br></br>Hepatitis is a slow-to-develop but life-threatening ailment that can lead to cancer or catastrophic liver failure. Many liver doctors had been awaiting the action the FDA took last night. Unsatisfied with two drugs already on the market, which have severe limitations, the doctors held off treatment for many patients healthy enough to wait. They also had been seeking a new treatment for seriously ill patients who have exhausted all other options.</br></br>"It works dramatically" in many patients for whom another antiviral drug, lamviudine, has stopped working, said Eugene Schiff, head of the Center for Liver Diseases at the University of Miami School of Medicine and a consultant to Gilead. "It's not a perfect drug, but there's no question it's an advance in hepatitis B."</br></br>The new drug is one of a growing number of spinoffs from the nation's investment in AIDS research. It was originally developed as an AIDS drug but proved too toxic in that use and was turned down by the FDA. However, it proved effective against the hepatitis B virus at far lower, and therefore safer, doses. It works by blocking reproduction of the virus.