Gilead Sciences Inc.’s experimental hepatitis C drug that lessens side effects and reduces length of treatment time is safe and effective against the disease, U.S. regulators said.
The medicine, sofosbuvir, has “a favorable benefit-risk assessment,” Food and Drug Administration staff said today in a review ahead of an Oct. 25 meeting of advisers to discuss the therapy. The FDA also will host an advisory panel tomorrow for Johnson & Johnson and Medivir AB’s hepatitis C drug simeprevir.
Gilead, J&J, Medivir, AbbVie Inc. and Bristol Myers Squibb Co. are among companies working on new hepatitis C drugs that alleviate the burden of current treatments that include interferon injections, which can cause flu-like symptoms. The total market for hepatitis C drugs may reach more than $100 billion over a decade, according to Bloomberg Industries.
For some patients, sofosbuvir “provides the first all-oral, interferon-free treatment, as well as a shorter treatment duration and improved safety profile compared to the current standard of care interferon-based regimen,” FDA staff wrote in the report.
Sofosbuvir is estimated to generate $2 billion in sales next year, according to the average of eight analysts’ estimates compiled by Bloomberg.
Gilead rose 1.4 percent to $69.01 at the close in New York. The company’s shares have gained 88 percent this year.
The FDA didn’t find any heart risks associated with sofosbuvir after Bristol-Myers and Idenix Pharmaceuticals Inc. discontinued development of drugs in the same class last year based on cardiovascular safety concerns.
Gilead is seeking FDA approval of once-daily sofosbuvir combined for the majority of patients with pegylated interferon and another pill call ribavirin, both of which make up the backbone of current treatment for the virus as part of a regimen that can last as long as 48 weeks. Sofosbuvir can cut the treatment time to 12 weeks. J&J’s simeprevir gets therapy down to 24 weeks.
The FDA is scheduled to decide whether to approve sofosbuvir by Dec. 8, and simeprevir by Nov. 27.
For the majority of current patients interferon and ribavirin are combined with Merck & Co.’s Victrelis and Vertex Pharmaceuticals Inc.’s Incivek. Victrelis, Incivek and J&J’s simeprevir are protease inhibitors that battle genotype 1 hepatitis C, the most common form of the disease. Sofosbuvir is the first in a new class of drugs called nucleotide polymerase inhibitors and is effective across all six hepatitis C genotypes.
About 4 million Americans have the disease, which can cause liver cirrhosis, according to the National Institutes of Health. The disease can be passed through infected blood or body fluids, most commonly through needle-sharing by drug users. About 70 percent of U.S. hepatitis C patients carry the genotype 1 infection.
Gilead studied an all-oral combination of sofosbuvir and ribavirin for genotype 2 and genotype 3 patients and a combination with pegylated interferon and ribavirin for patients with the other genotypes, including 1, who haven’t been treated before.
Sofosbuvir combined with pegylated interferon and ribavirin 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 found data on patients with genotypes 5 and 6 to be insufficient to determine dosing because Gilead only studied 7 patients total with those types of hepatitis C.
“This is a two- or three-stage program,” John McHutchison, senior vice president of liver disease therapeutics at Gilead, said in an interview. “This is the first approval.”
Gilead is researching an all-oral combination of sofosbuvir and another Gilead drug ledipasvir the company hopes will hit the market about a year after sofosbuvir itself.
“Sofosbuvir seems to be the future of many of these highly effective all oral regimens,” McHutchison said.
FDA workers recommended yesterday potential simeprevir users be screened for a genetic mutation called Q80K polymorphism that renders the drug ineffective. No such suggestion was made regarding sofosbuvir.
Data from a mid-stage study on a combination of simeprevir and sofosbuvir with or without ribavirin are expected to be released in early November at the American Association for the Study of Liver Diseases’ annual conference in Washington, D.C.