TGA approves third hep C drug currently awaiting PBS listing.

The Therapeutic Goods Administration (TGA) has now approved daclatasvir (Daklinza®) for use in Australia. This now means that all three hepatitis medicines currently being considered by the Government for listing on the Pharmaceutical Benefits Scheme (PBS) have received TGA approval. This means the only barriers to PBS listings for Daclatasvir, sofosbuvir and Harvoni® is the negotiations between the government and the pharmaceutical companies and then Cabinet approval.

The TGA approved use of daclatasvir in combination with sofosbuvir for the treatment of hepatitis C, genotypes 1 and 3. It also extended the approval for its use as an all oral therapy in combination with asunaprevir for the treatment of genotype 1b. However, asunaprevir has not yet been recommended for PBS listing.

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