FDA Approvals: Hep C Drug, Thyroid Cancer Drug, Avian Flu Vaccine — Physician’s First Watch
FDA Approvals: Hep C Drug, Thyroid Cancer Drug, Avian Flu Vaccine
By Amy Orciari Herman
Friday was a busy day at the FDA, with at least three new approvals:
Simeprevir: The protease inhibitor simeprevir (Olysio) is now approved to treat chronic hepatitis C virus infection. It's intended for use as part of a combination antiviral regimen (e.g., with peginterferon-alfa and ribavirin) in HCV-infected patients with compensated liver disease.
Sorafenib: Previously approved to treat certain kidney and liver cancers, sorafenib (Nexavar) may now be used in patients with metastatic, differentiated thyroid cancer. The drug is an oral kinase inhibitor.
Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted: The FDA approved the first adjuvanted vaccine for the prevention of H5N1 avian influenza. It's not intended for commercial use; rather, it will be included in the nation's stockpile for distribution by public health officials if the virus develops the ability to spread efficiently from human to human.