The FDA Approves Incivek For The Treatment Of Hepatitis C: New Treatment Doubles Cure Rates for 80,000 Bay Area Residents Living with Disease26 May 2011
Vertex Pharmaceuticals’ new treatment for hepatitis C: Incivek.
During clinical trials, patients new to Incivek treatments showed doubled cure rates.
There is good news for the more than 4 million Americans living with hepatitis C, including about 80,000 people in the San Francisco Bay Area.
This week the Food and Drug Administration approved a new hepatitis C treatment from Vertex Pharmaceuticals, Inc., called Incivek. During clinical trials, patients new to treatments showed doubled cure rates and decreased treatment durations. Incivek was approved for a broad group of people with genotype 1 chronic hepatitis C, the most common form of the virus.
Clinical data showed that 79% of (four out of five) people new to treatment achieved a viral cure when they received Incivek for 12 weeks in combination with pegylated-interferon and ribavirin.
It’s expected that more than 60% of people who are new to treatment or who relapsed after a prior course of treatment will complete all treatment in 24 weeks, half the time required with pegylated-interferon and ribavirin alone.
Vertex also launched a comprehensive patient assistance and reimbursement program to support its belief that no patient should have to go without one of its treatments due to cost alone. The company will provide free Incivek pills for people without health insurance and who have an annual household income that falls below $100,000. In some cases, the assistance program will also cover co-pay or co-insurance fees.
Hepatitis C is an infectious disease that is spread through the blood, including by sharing needles or having sex with an infected person. About 4 million people in the U.S. have the disease, and many people do not know they are infected. Hepatitis C can cause liver damage, cirrhosis, liver failure or cancer and is the leading cause of liver transplants in the country.
The approval is for people new to treatments as well as those who were not cured despite a previous course of treatment with available medicines (prior relapsers, partial responders and null responders).
Incivek and Merck & Co.’s Victrelis, which was approved earlier this month, are the first new breakthrough treatments for the liver disease to be approved in 20 years.
Vertex owns the North American marketing rights to Incivek, known as telaprevir in clinical trials, and is seeking marketing approval in other countries through partnerships, including an agreement with Johnson & Johnson. This highly anticipated pill is now available in pharmacies.
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