FDA Actions
The FDA has approved two new drugs for the treatment of chronic hepatitis C virus infections. Simeprevir was given the green light in late November and sofosbuvir was approved 2 weeks later. Simeprevir is a protease inhibitor similar to currently available protease inhibitors (boceprevir and telaprevir) and is indicated for adults, in combination with peginterferon-alpha and ribavirin, for adults with compensated liver disease, including cirrhosis, who have not received previous treatment or for whom previous treatment has not been effective. In both groups, about 80% achieved sustained virological reponse. Simeprevir is marketed by Janssen Pharmaceuticals as Olysio. Sofosbuvir is a nucleotide analog inhibitor, a new class of anti-hepatitis C drugs. It was approved with the “breakthrough therapy” designation. It is the first drug to be approved for use without interferon for certain hepatitis C infections, although it should be used with ribavirin and interferon for most indications, including all three common genotypes. Sofosbuvir is marketed by Gilead Pharmaceuticals as Sovaldi.
The FDA has approved obinutuzumab for use in combination with chlorambucil for the treatment of chronic lymphocytic leukemia (CLL) in previously untreated patients. The drug is the first agent to be approved under the FDA’s new “breakthrough therapy” designation — an expedited approval process for drugs that treat serious or life-threatening conditions that may be granted if the drug potentially offers substantial improvement over available therapies. Obinutuzumab’s approval was based on a study of 356 patients in an open-label trial of the drug plus chlorambucil vs chlorambucil alone, which showed that the two drugs resulted in progression-free survival of 23 months vs 11.1 months for the single agent. Obinutuzumab is marketed by Genentech as Gazyva.
The FDA has approved generic rabeprazole (Aciphex). This is the fourth generic proton pump inhibitor (PPI) to be approved following omeprazole (Prilosec), omeprazole/sodium bicarbonate (Zegerid), pantoprazole (Protonix), and lansoprazole (Prevacid). Generic rabeprazole is indicated to treat gastroesophageal reflux in adults and adolescents aged 12 years and older. Like the branded version, generic rabeprazole is provided in a 20 mg delayed-release version that is dosed once daily. Five generic manufacturers have received FDA approval to market the drug.
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