Telaprevir (Incivek) Approved
NEW YORK - The FDA approved Vertex Pharmaceuticals Inc.'s hepatitis C drug
Incivek on Monday, making it the second new treatment to be approved in the
last two weeks.
Incivek is a highly-anticipated pill that is expected to have annual sales
in the billions. It is approved for patients who have some liver damage from
hepatitis C who either have not been treated, or were not cured by other
drugs. Patients on Incivek take two pills three times per day.
The Cambridge, Mass., company started a nationwide campaign to increase
awareness of the disease in advance of Incivek's approval, and it said
Incivek will be available in pharmacies later this week.
The company says a 12-week course of treatment will cost $49,200, compared
to $30,000 for standard therapies.
Hepatitis C is an infectious disease that is spread through the blood,
including by sharing needles or having sex with an infected person. Vertex
said 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.
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.
In clinical trials, patients were treated with a combination of Incivek and
standard therapies for 12 weeks. They continued on the standard treatments
for another 36 weeks, but many of them were cured within 24 weeks. Vertex
said about 79 percent of previously untreated patients were cured after
treatment with Incivek. The drug was also much more effective in patients
who had relapsed, had some response but not a cure, or had no response to
Both Incivek and Victrelis block an enzyme that helps the virus reproduce.
Incivek is seen by Wall Street analysts as the more effective of the two
drugs and is expected to have greater sales. Victrelis is a pill taken three
times per day.
The most common side effects of Incivek are fatigue, itching, nausea,
diarrhea, vomiting, taste changes, and anal or rectal problems. More serious
side effects include rash, anemia, low red blood cell count, and birth
defects in pregnant women. The standard treatments - including the IV drug
pegylated interferon and the pill ribavirin - can cause flu-like symptoms
that can last for months, but less than half of patients are cured.
Vertex owns the North American marketing rights to Incivek, also known as
telaprevir, and is seeking marketing approval in other countries through
partnerships, including an agreement with Johnson & Johnson. The company
said it has a 115-person sales team to support the drug, and will give
Incivek for free to people with no health insurance and annual household
income of less than $100,000. It will also cover some co-pay or co-insurance