FDA decision on Rebif.Positive results from a large clinical trial of Rebif, an interferon interferon (ĭn'tərfēr`ŏn), any of a group of proteins produced by cells in the body in response to an attack by a virus. A cell infected by a virus releases minute amounts of interferons, which attach themselves to neighboring cells, beta-la drug, in Europe, Canada, and Australia were published in the November 7, 1998, issue of The Lancet. Rebif delivers a larger amount of active drug than Avonex, which is identical to Rebif in chemical composition. Rebif is taken by self-injection 3 times a week. Data showed the benefits include a 30% reduction in the number of MS attacks. A significant number of people had no attacks at all during the 2-year study. Hospitalizations and use of steroids were reduced, and the time to onset of increased disability was lengthened length·en tr. & intr.v. length·ened, length·en·ing, length·ens To make or become longer. length  en·er n. .
The FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. reviewed these data and ruled that the benefits of Rebif are not sufficiently different to warrant ending market protections given to Avonex under the Orphan Drug orphan drug, drug developed under the U.S. Orphan Drug Act (1983) to treat a disease that affects fewer than 200,000 people in the United States. The orphan drug law offers tax breaks and a seven-year monopoly on drug sales to induce companies to undertake the Act. Thus, Rebif can not be marketed in the U.S. until 2003. |
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