Showing posts sorted by date for query Simeprevir. Sort by relevance Show all posts
Showing posts sorted by date for query Simeprevir. Sort by relevance Show all posts

Thursday, January 1, 2015

FDA Approves Olysio (simeprevir) in Combination with Sofosbuvir for Genotype 1 Chronic Hepatitis C Infection


Sofosbuvir.svgSimeprevir.svg

In continuation of my update on Sofosbuvir (left) and  Simeprevir (right)

Janssen Therapeutics, Division of Janssen Products, LP (Janssen) announced the U.S. Food and Drug Administration (FDA) has approved Olysio (simeprevir), a hepatitis C virus (HCV) NS3/4A protease inhibitor, in combination with sofosbuvir as an all-oral, interferon- and ribavirin-free treatment option for genotype 1 chronic hepatitis C (CHC) infection in adult patients as part of a combination antiviral treatment regimen. Sofosbuvir is an HCV nucleotide analog NS5B polymerase inhibitor developed by Gilead Sciences, Inc.

Friday, November 21, 2014

FDA Approves Olysio (simeprevir) in Combination with Sofosbuvir for Genotype 1 Chronic Hepatitis C Infection


In continuation of my update on sofosbuvir

Janssen Therapeutics, Division of Janssen Products, LP (Janssen) announced the U.S. Food and Drug Administration (FDA) has approved Olysio (simeprevir), a hepatitis C virus (HCV) NS3/4A protease inhibitor, in combination withsofosbuvir as an all-oral, interferon- and ribavirin-free treatment option for genotype 1 chronic hepatitis C (CHC) infection in adult patients as part of a combination antiviral treatment regimen. Sofosbuvir is an HCV nucleotide analog NS5B polymerase inhibitor developed by Gilead Sciences, Inc.

Friday, January 31, 2014

New Hepatitis C Drug Sovaldi Approved by FDA

A new hepatitis C drug that can be taken as a pill once a day was approved by the U.S. Food and Drug Administration on Friday.
The drug, called Sovaldi and made by Calif.-based Gilead Sciences Inc., works faster and should be much simpler to take for the millions of Americans who have the virus, which can destroy the liver if left untreated.
The FDA said in a statement that Sovaldi is to be taken with older drugs to treat the main forms of hepatitis C. The agency added that 3.2 million Americans have the disease, and people born between 1945 and 1965 are five times more likely to be infected.
Current treatments can take almost a year to beat back the virus, and involve weekly injections of the drug interferon, which can cause diarrhea and flu-like symptoms, the FDA said. Only about 75 percent of patients are cured with current treatments. In clinical trials, Sovaldi cured close to 90 percent of patients in just 12 weeks, when combined with the standard treatment.
Sovaldi (sofosbuvir) is the second hepatitis C drug to be approved by the FDA in the past two weeks. In November, the agency gave its blessing to Olysio (simeprevir), made by Janssen Pharmaceuticals, of Raritan, N.J.
Symptoms of hepatitis C disease may not appear until two or three decades after infection, though the virus can cause liver failure, cirrhosis and cancer, the FDA said.

Friday, December 6, 2013

Olysio (simeprevir) Approved By FDA To Treat Hepatitis C Virus | MediMoon



We know that, Simeprevir (see structure below, formerly TMC435; trade name Olysio) is a drug for the treatment and cure of hepatitis C. It was developed by Medivir and Johnson & Johnson's pharmaceutical division Janssen Pharmaceutica. In the United States, simeprevir is approved by the Food and Drug Administration for use in combination withpeginterferon-alfa and ribavirin. Simeprevir has been approved in Japan for the treatment of chronic hepatitis C infection, genotype 1



Olysio (simeprevir) Approved By FDA To Treat Hepatitis C Virus | MediMoon