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FDA Approves $94500 Hepatitis C Drug From Gilead

The Food and Drug Administration has approved a daily pill that can cure the most common type of hepatitis C without the typical pill and injection combination method that has long been used to fight the chronic virus.

The medication’s cost of $1,125 per day has already drawn criticism against Gildean Sciences, whose pricing method for an older hepatitis medication has been criticized by patients, politicians and health companies around the world, Fox News reported.

The FDA announced it cleared the Harvoni combo drug for patients with genotype 1 of hepatitis C, a virus that destroys the liver and accounts for about 70% of the 3.2 million cases of hepatitis C in the United States. For these patients, the older combination of injections and antiviral pills that cause flu-like symptoms can be a thing of the past. This is the first combination pill of ledipasvir and sofosbuvir that does not require the antiviral medications ribavirin or interferon to be taken at the same time.

[quote text_size=”small” author=”– Dr. Edward Cox” author_title=”Director of the Office of Antimicrobial Products, FDA Center for Drug Evaluation and Research”]

Now, patients and health care professionals have multiple treatment options, including a combination pill to help simplify treatment regimens.

[/quote]

Harvoni was tested in three clinical studies of more than 1,500 people who did not respond to previous treatments or had not been previously treated. The studies found that fatigue and headaches were the most common side effects, USA Today reported.

Analysts expect Harvoni to bring the company billions in new sales. The new drug will cost $94,500 for a 12-week supply, although an estimated 40% of patients may be able to take the medication for just 8 weeks for a cost of $63,000. This shorter treatment is recommended for patients who have not been previously treated and do not have advanced liver damage.

Despite the criticism over the high price, Gildean executives say the drug is priced slightly lower than the current treatment. Sovaldi along with a cocktail of two drugs has an estimated cost of $95,000 for 12 weeks.

Members of the Senate have requested Gildean provide documents detailing their decision as to the price of the drug, the San Jose Mercury News reported.

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