Product case study Vitravene

In August 1998, Vitravene (tradename) became the first (and thus far the only) antisense product to be approved for general medical use by the FDA. It gained approval within the EU the following year, although it has since been withdrawn from the EU market due to commercial rather than technical reasons. The product is a 21-nucleotide phosphorothioate based product of the following base sequence: 5'-G-C-G-T-T-T-G-C-T-C-T-T-C-T-T-C-T-T-G-C-G-3'

Developed by the US company, Isis, Vitravene is used to treat cytomegalovirus (CMV) retinitis in AIDS patients. It is synthesized chemically and formulated as a sterile solution (6.6 mg active drug/ml) in WFI using a bicarbonate buffer to maintain a final product pH of 8.7.

The product inhibits replication of human CMV (HCMV) via an antisense mechanism. Its nucleotide sequence is complementary to a sequence in mRNA transcripts of the major immediate early region (IE2 region) of HCMV. These mRNAs code for several essential viral proteins and blocking their synthesis effectively inhibits viral replication.

Administration is by direct injection of 0.05 ml product into the eye (intravitreal injection), initially once every 2 weeks and subsequently once every 4 weeks. Animal studies (rabbits) indicated that the product is cleared from the eye over the course of 7-10 days, with direct nucle-ase-mediated metabolism representing the primary route of elimination. The most commonly observed side effect is ocular inflammation, which typically occurs in one in every four patients.

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