J&J, Medivir Win U.S. FDA Approval for Hepatitis C Pill

Johnson & Johnson (JNJ) and Medivir AB (MVIRB) won U.S. approval for their pill to treat chronic hepatitis C, the first drug allowed for sale in a competition to bring new treatments for the virus to market.

The Food and Drug Administration cleared simeprevir, to be called Olysio, in combination with other medicines for the viral disease that damages the liver, the agency said in a statement. The drug can shorten current treatment by half, limiting interferon injections that may cause flu-like symptoms.

J&J, Medivir, Gilead Sciences Inc. (GILD) and Bristol-Myers Squibb Co. (BMY) are among companies developing new pills for the virus to alleviate the burden of current therapies. The market for hepatitis C drugs may reach more than $100 billion over a decade, Bloomberg Industries said. Olysio may generate $447 million for New Brunswick, New Jersey-based J&J in 2016, according to the average of four analysts’ estimates compiled by Bloomberg.

“Olysio is the third FDA-approved protease inhibitor to treat chronic hepatitis C virus infection, and provides health professionals and patients with a new, effective treatment for this serious disease,” Edward Cox, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research, said in yesterday’s statement.

Baby Boomers

About 4 million Americans have the disease, which can cause liver cirrhosis, according to the National Institutes of Health. Hepatitis C can be passed through infected blood or body fluids, most commonly through needle-sharing by drug users. The virus may be carried for years without symptoms and the U.S. Centers for Disease Control and Prevention recommended last year that baby boomers, defined by the agency as those born from 1945 to 1965, get tested for the infection.

The medicine from J&J, the world’s biggest seller of health-care products, and Huddinge, Sweden-based Medivir, is for use in combination with pegylated interferon and a pill called ribavirin for those with genotype 1, the most common form of the disease, J&J said in a statement. Interferon and ribavirin make up the backbone of current treatments. Most patients now take the combination with Merck & Co.’s Victrelis or Vertex Pharmaceuticals Inc. (VRTX)’s Incivek for as long as 48 weeks.

Olysio is in a class of drugs that also include Victrelis and Incivek, though patients who used it in clinical trials were treated in just 24 weeks. The experimental hepatitis C pills are designed to be more convenient to take, reduce treatment times and avoid the side effects of current therapies.

Study Data

Clinical studies showed 80 percent of patients given Olysio who had never been treated before no longer had detectable virus in their blood and 79 percent of those who tried other treatments before Olysio were cured as well, the FDA said.

The FDA is supposed to decide by Dec. 8 whether to approve Foster City, California-based Gilead’s sofosbuvir. If cleared for sale, the medicine would be the first all-oral treatment for two forms of hepatitis C that make up as many as 25 percent of patients. Hepatitis C is divided into six genotypes. Genotype 1 patients account for about 70 percent of those in the U.S. who have the disease.

Olysio’s label suggests patients be screened for a genetic mutation called Q80K polymorphism that renders the drug ineffective. In clinical trials the mutation showed up in about 48 percent of U.S. patients with genotype 1a infection, the more common subtype in the U.S. compared with genotype 1b, which is more prevalent in Europe and Asia and isn’t typically associated with the mutation.

Olysio users also are cautioned to limit sun exposure as some clinical trial participants experience serious photosensitivity reactions requiring hospitalization.

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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