Gilead Wins FDA Approval for Blockbuster Hepatitis C Pill

Gilead Sciences Inc. (GILD) won U.S. approval for a hepatitis C pill that may generate more than $6 billion in annual sales as it leads a market for drugs that work faster to combat the disease with fewer side effects.

The $84,000 treatment is the first all-oral combination for some hepatitis C patients that helps avoid the flu-like symptoms caused by interferon injections, part of the current standard of treatment. The Food and Drug Administration said today it cleared sofosbuvir, which Gilead will call Sovaldi, for use with other drugs depending on the type of illness.

Gilead, Johnson & Johnson (JNJ), AbbVie Inc. (ABBV) and Bristol-Myers Squibb Co. are among companies vying to market new drugs that reduce or eliminate the need for interferon shots, while maintaining high cure rates. Sovaldi is projected to be Gilead’s biggest product, generating $1.9 billion in revenue next year, and $6.6 billion in 2016, according to the average of eight analysts’ estimates compiled by Bloomberg.

“Today’s approval represents a significant shift in the treatment paradigm for some patients with chronic hepatitis C,” Edward Cox, director of the Office of Antimicrobial Products in the FDA’s drug evaluation center, said in a statement.

Sales of hepatitis C medicines may reach more than $100 billion over a decade, according to Bloomberg Industries. The FDA approved J&J and Medivir AB (MVIRB)’s hepatitis C drug Olysio on Nov. 22. The drug can cut current treatment times in half to 24 weeks, limiting interferon exposure.

Potential Patients

Sovaldi works in 12 weeks for most patients, and the wholesale price will be $28,000 for a 28-day supply of tablets, Foster City, California-based Gilead said in a statement. The drug is prescribed to be taken once a day.

About 4 million Americans have hepatitis C, which can cause liver cirrhosis, according to the National Institutes of Health. The disease, which is classified into six genotypes, can be passed through infected blood or body fluids, most commonly through needle-sharing.

The most common genotype is 1, which infects about 70 percent of hepatitis C patients in the U.S. The FDA approved Gilead’s once-daily pill for genotype 1 and 4 patients in combination with pegylated interferon and the pill ribavirin, Gilead said.

The sofosbuvir cocktail taken for 12 weeks cured 90 percent of patients with genotypes 1, 4, 5 and 6 who hadn’t been treated before, Gilead said. FDA staff said in a report Oct. 23 that the drugmaker didn’t study enough patients with genotype 5 or 6.

Merck Drug

Sovaldi also gained clearance for genotypes 2 and 3, which account for as many as 25 percent of infections, in combination with ribavirin, marking it the first all-oral treatment.

For the majority of current patients, interferon and ribavirin are used with Merck & Co.’s Victrelis or Vertex Pharmaceuticals Inc. (VRTX)’s Incivek. Victrelis, Incivek and J&J’s Olysio are protease inhibitors that battle genotype 1 hepatitis C. Sovaldi is be the first in a new class of drugs called nucleotide polymerase inhibitors.

Gilead, the world’s biggest maker of AIDS drugs, said it hopes to market an all-oral combination for genotype 1 patients in about a year.

To contact the reporter on this story: Anna Edney in Washington at aedney@bloomberg.net

To contact the editor responsible for this story: Reg Gale at rgale5@bloomberg.net

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