A new drug, peramivir, claimed to be a highly potent formulation for combating the virulent forms of the H5N1 bird flu virus has been credited with a fast-track review by the Food and Drug Administration.
This novel drug, produced by the pharmaceutical company BioCryst can be injected intravenously. Promising results have been obtained from drug trials conducted against different bird flu strains. If successful and approved we could soon have a new form of anti-viral therapy to effectively manage the bird flu threat.''The FDA's decision supports our belief in the potential of peramivir as an effective therapy for the treatment of influenza, including highly virulent, life-threatening strains like those associated with avian influenza,'' said BioCryst Chairman and CEO Charles Bugg.
The FDA had approved the launch of human trials to test the efficacy and safety of the intravenous formulation of peramivir, last December. Following approval, it has been planned to initiate phase I clinical trials of the drug within March 2006. The drug would be tested on patients suffering from acute influenza infection.
In addition, developing an intramuscular form of the drug is also under consideration. This is belived to be tested on victims of seasonal bird flu. Both the clinical trials are jointly conducted by the National Institutes of Allergy and Infectious Diseases at the National Institute of Health.
Only those drugs, used for the treatment of severe diseases for which there is an unfulfiled medical need would be granted fast-track status by the FDA. A six month review of the sponsor’s drug by the FDA would also be included in the fast-track package.
