Gilead Sciences, Inc. (NASDAQ: GILD) announced today that the China Food and Drug Administration (CFDA) has approved Sovaldi® (sofosbuvir 400mg), a once-daily oral nucleotide analog polymerase inhibitor for the treatment of chronic hepatitis C virus (HCV) infection. Sovaldi was approved for the treatment of adults and adolescents (aged 12 to 18 years) infected with HCV genotype 1, 2, 3, 4, 5 or 6 as a component of a combination antiviral treatment regimen. Sovaldi is the first Gilead HCV medicine approved in China.
The approval of Sovaldi is supported by a Phase 3 study conducted in China, presented earlier this year at the Asian Pacific Association for the Study of the Liver (APASL) meeting. SVR12 (HCV RNA undetectable 12 weeks after completing therapy) rates for Chinese HCV patients with genotype 1, 2, 3 or 6 ranged from 92-100 percent. The study evaluated Sovaldi in combination with ribavirin (RBV) or pegylated interferon+ribavirin (PegIFN+RBV) across a range of difficult-to-cure patient populations, including treatment-experienced patients and those with compensated cirrhosis. In this study, the safety profiles of the regimens were consistent with the known side effects of pegylated interferon and/or ribavirin. The most common adverse events were hematological abnormalities and pyrexia.
The decision is a major blow to the access to drug movement, says MSF
In direct contradiction to its earlier order, the Controller General of Patents, Designs and Trademark granted American pharmaceutical company Gilead Sciences the patent for the blockbuster Hepatitis C drug Sofosbuvir (brand name Sovaldi) in India.
An application for the same patent was first rejected in January 2015 as lacking inventiveness and novelty.
A $100 million ad blitz has whipped up patient demand for Harvoni, the $1,100-a-pill hepatitis C treatment, even as the drug’s price has drawn a barrage of lawsuits, state investigations, and sharp condemnation from members of Congress.
STAT analyzed data from media research firms iSpot.tv and Kantar Media for the most detailed look to date at the aggressive consumer marketing strategy for Harvoni, made by Gilead Sciences Inc. of Foster City, Calif.
At a time when some insurers have been reluctant to cover — and some physicians have been reluctant to prescribe — such an expensive drug, Gilead has pushed Harvoni in front of potential patients at every opportunity: as they read celebrity gossip, watch science fiction shows, follow the news, and more. As a result, doctors say patients are coming in asking for the drug by name, apparently not deterred by the cost or by the heavy political and legal fire aimed at Harvoni’s price tag.