Roundup: FDA Approves New Drugs
Primary care practitioners should be aware of 3 new FDA approvals that may be useful when treating patients.
Simeprevir: Hepatitis C Virus
The U.S. Food and Drug Administration approved the protease inhibitor, simeprevir (Olysio), for the treatment of chronic hepatitis C virus.
The drug, intended for use by adults with compensated liver disease, was evaluated in 5 clinical studies with 2026 participants randomly assigned either simeprevir plus peginterferon-alfa and ribavirin or placebo plus peginterferon-alfa and ribavirin.1
Of the participants receiving simeprevir, 80% showed sustained virologic response versus only 50% of those given placebo.
Sorafenib: Thyroid Cancer
Sorafenib (Nexavar), previously approved to treat kidney and liver cancers, is now approved for the treatment of metastic thyroid cancer.
Sorafenib, which inhibits proteins found in cancer cells, is intended for patients with recurrent or progressive differentiated thyroid cancer no longer responding to radioactive iodine treatment.
In a clinical study of 417 participants, sorafenib increased the time spent without cancer progression by 41% and doubled the time spent without progression for half of the participants—10.8 months versus 5.8 months for those receiving placebo.2
Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted: Avian Flu
The FDA has approved the first vaccine covering H5N1 avian influenza, also known as “bird flu.” The vaccine is not intended for commercial use, but rather will be held in storage to be distributed in the event of a wide-scale avian flu outbreak.
The vaccine contains an adjuvant, making it possible to use only a small amount of influenza proteins per dose to provoke the desired immune response.
This also increases the total number of available vaccine doses available. In a study of 2000 vaccinated adults, researchers analyzed immune response and found that 91% of those between the ages of 18 and 64 years and 74% of those 65 years and older developed antibodies that could effectively reduce the risk of infection.3
References:
1. Yao, S. FDA approves new treatment for hepatitis C virus [press release] http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm376449.htm
2. Goodin T. FDA approves Nexavar to treat type of thyroid cancer [press release]. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm376443.htm
3. Rodriguez J. FDA approves first adjuvanted vaccine for prevention of H5N1 avian influenza [press release]. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm376444.htm