Gilead Sciences’ Harvoni gains EU approval

The European Commission yesterday granted marketing authorization for US biotech antiviral specialists Gilead Sciences’ (Nasdaq: GILD) Harvoni (ledipasvir 90mg/sofosbuvir 400mg), the first once-daily single tablet regimen to treat the majority of chronic hepatitis C genotype 1 and 4 infection in adults. The news helped move Gilead’s shares 1.7% higher to $102.19 in morning trading on Tuesday.

Harvoni combines the NS5A inhibitor ledipasvir (LDV) with the nucleotide analog polymerase inhibitor sofosbuvir (SOF), approved by the European Commission under the trade name Sovaldi in January 2014. Sovaldi has already established itself as a mega-blockbuster, generating sales of $8.6 billion in the first nine months of this year.

Approval follows EMA accelerated assessment

The marketing authorization is based on the clinical development program that included more than 2,000 patients with HCV infection, and follows an accelerated assessment by the European Medicines Agency, a designation that is granted to new medicines of major public health interest. It allows for the marketing of Harvoni in all 28 countries of the European Union.