FDA approves new daily pill to cure hepatitis C

WASHINGTON – Federal health officials have approved a daily pill that can cure the most common form of hepatitis C without the grueling pill-and-injection cocktail long used to treat the virus.

But the drug’s $1,125-per-pill price is sure to increase criticism of drugmaker Gilead Sciences, whose pricing strategy for an older hepatitis drug has already drawn scorn from patient groups, insurers and politicians.

The Food and Drug Administration said Friday it cleared Gilead’s Harvoni combination pill for patients with genotype 1 of hepatitis C, a form of the liver-destroying virus that accounts for 70 percent of the estimated 3.2 million cases in the U.S. For the first time, those patients will not have to take a decades-old combination of antiviral pills and shots that causes flu-like side effects.

The new pill combines Gilead’s blockbuster Sovaldi, approved last December, with a new antiviral drug called ledipasvir, which attacks the virus using a different mechanism. The dual-acting approach mimics drug combinations Gilead has long used to treat HIV.

It’s another breakthrough for Gilead, which analysts expect to bring in billions of dollars in new sales. The company says the new drug will cost $94,500 for a 12-week supply. About 40 percent of patients may be able to take the drug for eight weeks, reducing the price to about $63,000.