The FDA approves on December 6, the third drug to have the coveted Breakthrough Therapy Designation (BTD). The approval is for Gilead Sciences’ non-orphan drug Sovaldi (Sofosbuvir) for the treatment of patients with chronic Hepatitis C (HCV). What is a “breakthrough” about this approval is the fact that Sovaldi is the first drug that safely and with efficacy, treats particular types of HCV without the need for co-administration of Interferon.
Per Gilead Sciences’ Press Release, approximately 4 million Americans are infected with HCV in the United States. The current standard of care for HCV is up to 48 weeks with a pegylated interferon (peg-IFN)/ribavirin (RBV)-containing regimen, depending on the patient’s particular HCV genotype. Sovaldi is a once-daily oral nucleotide analog polymerase inhibitor receiving approval for chronic HCV as a part of a combination antiviral treatment regimen. The drug blocks a protein used by HCV to replicate.
According to a Reuters online article, most patients will be…
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DRUG APPROVALS BY DR ANTHONY MELVIN CRASTO
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