Reuters Health Information (2004-10-06): Roche hepatitis C drugs win fast review for use in HIV patients
Roche hepatitis C drugs win fast review for use in HIV patients
Last Updated: 2004-10-06 15:57:19 -0400 (Reuters Health)
NEW YORK (Reuters) - Roche Holding SA on Wednesday said
U.S. regulators would give priority review to whether the company's
combination treatment for hepatitis C should be used by patients also
infected with HIV.
Roche's injectable interferon Pegasys and oral ribavirin are already
approved for the treatment of hepatitis C virus infection. Since a
significant percentage of people infected with HIV are also infected
with the hepatitis C virus, Roche has asked for permission to market
the dual therapy for this population.
Drugs given priority review status are reviewed by the U.S. Food and
Drug Administration within six months, rather than the typical review
time of up to one year.