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Abbvie Wins FDA Approval for the First-Ever Drug to Treat all Forms on Hep C

Friday, August 4, 2017   (0 Comments)
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CHICAGO – The hepatitis C market just got more crowded after the U.S. Food and Drug Administration (FDA) approved AbbVie (ABBV)’s Mavyret, a drug that will treat all types of HCV in an eight week timeframe.

With the approval, AbbVie has rival HCV drugmaker Gilead Sciences (GILD) squarely in its sights. AbbVie estimates that approximately 95 percent of U.S. HCV patients can be treated with Mavyret, including patients with compensated cirrhosis or without cirrhosis and those with limited treatment options, such as patients with chronic kidney disease (CKD.

AbbVie Chief Scientific Officer Michael Severino said the approval of Mavyret means patients and physicians have an option that cuts treatment for HCV to eight weeks, down from the 12 week regimen of Gilead’s top drugs, Sovaldi and Harvoni.

According to the FDA, Mavyret is the first treatment of eight weeks duration approved for all HCV genotypes 1-6 in adult patients without cirrhosis who have not been previously treated.

“This approval provides a shorter treatment duration for many patients, and also a treatment option for certain patients with genotype 1 infection, the most common HCV genotype in the United States, who were not successfully treated with other direct-acting antiviral treatments in the past,” Edward Cox, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research, said in a statement.

The approval of Mavyret was supported by data from nine across all major HCV genotypes (GT1-6) and special populations. Mavyret (glecaprevir/pibrentasvir) is a once-daily, ribavirin-free treatment for adults with chronic HCV. Mavyret combines two new direct-acting antiviral treatments that target and inhibit proteins essential for the replication of the hepatitis C virus.


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