Roche refiles dossier for Tamiflu in EU
Roche and partner Gilead Sciences have resubmitted an approval dossierfor their orally-active neuraminidase inhibitor Tamiflu (oseltamivir phosphate) in the European Union. The companies are seeking clearance for the drug in the treatment of influenza A and B in adults and children, as well as prevention of the infection in adolescents and adults.
Roche withdrew its original submission for Tamiflu in the EU after requests for more information on its activity against the B strain of the virus (Marketletter August 21, 2000), and now says it is hoping for approval and launch there before the next flu season.
Meantime, Roche has received the backing of a US Food and Drug Administration advisory committee for the use of valganciclovir as maintenance and induction therapy for cytomegalovirus retinitis in patients with AIDS. The recommendation comes on the back of clinical data comparing oral valganciclovir to Roche's injectable drug Cytovene (ganciclovir).
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