Bristol-Myers Squibb, the Pharmaceutical Company based in Princeton, New Jersey, has received approval from the Food and Drug Administration (FDA) to market the new product Daklinza (daclatasvir) with the use of sofosbuvir to treat hepatitis C virus (HCV) genotype 3 infections.
According to the FDA, Daklinza is the first drug that has demonstrated safety and efficacy to treat genotype 3 HCV infections without the need for co-administration of interferon or ribavirin, two FDA-approved drugs also used to treat HCV infection.
Hepatitis C is a viral disease that causes inflammation of the liver that can lead to diminished liver function, or liver failure.
The release from the agency noted that most people infected with HCV have no symptoms of the disease until liver damage becomes apparent, which may take several years.
It also said that some people with chronic HCV infection develop scarring and poor liver function (cirrhosis) over many years, which can lead to complications such as bleeding, jaundice (yellowish eyes or skin), fluid accumulation in the abdomen, infections or liver cancer.
The Center for Disease Control and Prevention is also reported as saying that approximately 2.7 million Americans are infected with HCV of which approximately 10 percent are genotype 3.
Edward Cox, M.D., director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research, reportedly said, “Today’s approval provides a new option for patients with genotype 3 HCV, including those patients who cannot tolerate ribavirin.”
The most common side effects of Daklinza with sofosbuvir were fatigue and headache.
Daklinza carries a warning for patients and health care providers that serious slowing of the heart rate (symptomatic bradycardia) and cases requiring pacemaker intervention have been reported when amiodarone is co-administered with sofosbuvir in combination with another HCV direct-acting antiviral, including Daklinza. Co-administration of amiodarone with Daklinza in combination with sofosbuvir is not recommended.
Daklinza was reviewed under the FDA’s priority review program, which provides for an expedited review of drugs that treat serious conditions and, if approved, would provide significant improvement in safety or effectiveness.
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