UPDATED: FDA approves Gilead's highly anticipated hep C 'cure'

The FDA late Friday approved Sovaldi, a highly anticipated hepatitis C drug from Gilead Sciences ($GILD) that is expected to change the face of treatment for the difficult condition while earning up to $7 billion a year for the company.

Doctors have been "warehousing" patients waiting for the treatment. The big change, as noted by the FDA, is that the drug is an oral treatment that can be used without requiring interferon, the immune stimulant that causes severe side effects and which some patients just can't tolerate. The treatment may be able to cure as many as 85% of cases. The slowly developing but lethal virus affects about 3.2 million Americans.

"There are several different types of HCV infection," the FDA said. "Depending on the type of HCV infection a patient has, the treatment regimen could include Sovaldi and ribavirin or Sovaldi, ribavirin and peginterferon-alfa. Ribavirin and peginterferon-alfa are two drugs also used to treat HCV infection."

The advent of interferon-free treatments for hepatitis C is an advance that's "about as hot as I've ever seen," Dr. David Thomas, a liver specialist at Johns Hopkins University, told NPR ahead of the approval.

Michael Yee, an analyst with RBC Capital Markets, pointed out to investors that the the price of the drug will be $28,000 per bottle, or $84,000 for the standard 12-week combo treatment. But he points out that some patients will be taking it for 24 weeks, in which case Gilead gets $168,000. The drug will come with a copay assistance program that will make the copay less than $5 for eligible patients. The firm is projecting it will generate $225 million in sales in the first quarter and that peak sales of $7 billion to $8 billion are achieveable. 

That is because doctors are expected to adopt it quickly. "I believe that Sovaldi will have a major impact on public health by significantly increasing the number of Americans who are cured of hepatitis C," said Dr. Ira Jacobson, chief of the division of gastroenterology and hepatology at Weill Cornell Medical College and a principal investigator in the Sovaldi clinical trials, in a company statement.

As FierceBiotech points out, the drug is expected to be followed into the market by a host of other cocktail therapies for hepatitis C, including offerings from AbbVie ($ABBV) and Bristol-Myers Squibb ($BMY). 

- here's the release from the FDA
- read Gilead's statement
- check out the FierceBiotech story
- get more from NPR

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