On April 8, 2013 the company filed the NDA for review and the FDA has determined a target review date under the Prescription Drug User Fee Act of December 8.
The NDA has been submitted for the approval of sofosbuvir and ribavirin (RBV) as an oral therapy for people suffering from genotype 2 and 3 HCV infection, as well treatment for genotype 1, 4, 5 and 6 HCV infection, when used in combination with RBV and pegylated interferon (peg-IFN).
Sofosbuvir offers impressive cure rates among people suffering from genotype 2 and 3 HCV infection, according to researchers at Weill Cornell Medical College.
Around twenty-five percent of hepatitis C patients in the U.S. suffer from one of these two subtypes.
Trial results demonstrate the efficacy of SofosbuvirThe POSITRON trial of the drug included 207 participants. The trial had very positive patient response rates after three months therapy of sofosbuvir combined with ribavirin. The response rates were 93% in patients with genotype 2 and 61% in those with genotype 3.
Sofosbuvir was found to offer much more effective treatment than Interferon. Approximately half of hepatitis C patients are unable to use Interferon or refuse it completely.
This is mainly because Interferon can have quite severe side effects, including: heart failure, loss of vision, and a decrease of white blood cells.
Dr. Ira Jacobson, chief of the Division of Gastroenterology and Hepatology and Vincent Astor Distinguished Professor of Medicine at Weill Cornell Medical College, said:
"The new sofosbuvir therapy offers a much-needed alternative to standard therapy with interferon, which can cause significant side effects for hepatitis C patients.
"We have dreamed for years of being able to eliminate interferon from our hepatitis C regimens and this study is one of several that are finally bringing us very close to realizing that goal."
The FUSION Trial of the drug, which was led by Dr. David R. Nelson from the University of Florida at Gainesville, similarly tested the effectiveness of sofosbuvir plus ribavirin in hepatitis C patients who didn't respond to Interferon. The participants were evaluated at 12 and 16 weeks of therapy.
The study found that the longer the patients took the sofosbuvir combo, the higher their cure rate was.
Dr. Jacobson said:
"Given the absence to date of alternative therapies for patients with genotype 2 or 3 who have failed interferon therapy or for whom it is not an option, treatment with the new sofosbuvir regimen offers a vast improvement. But the optimal duration of treatment for genotype 3 patients, in order to maximize their chance of cure, remains undefined. It could be longer than 16 weeks."
Prevalence of hepatitis C170 million people are infected with hepatitis C around the world. It is responsible for over 350,000 deaths every year. Close to 4 million Americans suffer from hepatitis C.
Many patients experience no symptoms of hepatitis C and don't realize they are infected. However, if left untreated the disease can progress to cirrhosis, liver cancer and liver failure.
Hepatitis C Made Simple
Written by Joseph Nordqvist