Wednesday, October 30, 2013

Hepatitis C drug Gilead's sofosbuvir to get FDA Approval

Check out the positive review of Gilead Sciences Inc's hepatitis C drug - Sofosbuvir given by the ‘U.S. Food and Drug Administration’ (FDA).

Gilead Sciences’ much-anticipated hepatitis C drug, named as Sofosbuvir, has been given the thumbs up by an FDA advisory group. All 15 members of the Food and Drug Administration’s panel of virus experts have voted in favor of approving Sofosbuvir, a daily pill designed to treat several forms of Hepatitis C. Usually FDA follows the recommendations made by its advisory panels, but not required to do so. The FDA is expected to make the final decision regarding the approval of the drug by 8th of December 2013.

Hepatitis C drug Gilead's sofosbuvir

Around 3-4 million people in the U.S. are affected with hepatitis C, a severe blood-borne disease, that can lead to severe liver damage and organ failure. In fact, every year more than 15000 people in America die from hepatitis C-related diseases!

Earlier, the standard treatment for hepatitis C infection involved a 1 year regimen of pills and interferon injections that caused flu-like symptoms, diarrhea, nausea & other deadly side effects, and cured less than half of the patients suffering from Hepatitis C. Later in year 2011, the FDA approved two new drugs - Incivek from Vertex Pharmaceuticals Inc. and Victrelis from Merck & Co - which when combined with the older treatments, raised the cure rate to about 65-75 percent respectively.

The new Gilead's Sofosbuvir drug is said to have the ability to push the cure rates even higher. The once-a-day pill has been shown to cure nearly 90% of patients with Hepatitis C in just 12 weeks! What’s more, the FDA panel also didn’t find any unusual heart risks associated with the drug.

Now, Gilead Sciences Company is seeking FDA approval to market Sofosbuvir in combination with an existing treatment - Ribavirin - for patients affected with genotype 2 or 3 infection, and for those who are waiting for a liver transplant. Hence, if approved (which is expected), it will be the first ever all-oral treatment for genotypes 2 and 3 infections. Gilead is also planning to market Sofosbuvir in combination with Ribavirin & Interferon for patients with HCV genotype 1 infection (regardless of prior treatments), and for patients with genotypes 4, 5 and 6 infection (who have not been treated previously).

Hepatitis C is threatening to become a major health problem among baby boomers (those born between 1946 and 1955) and middle-age Americans. Gilead Sciences Inc. is just one of the half-dozen pharmaceutical companies that are trying hard to develop more effective treatment for this deadly virus. However, most industry analysts believe that the experimental drug from Gilead Sciences Inc. will outperform its rivals. According to analysts' estimates compiled by Bloomberg, Sofosbuvir is likely to generate over $2 billion in sales in 2015.


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