Canada Approves Simeprevir for Hepatitis C


Simeprevir-923604-59-5On November 20, 2013 Health Canada revealed the approval of Simeprevir, known as the brand name GALEXOS, to treat hepatitis C. Janssen, the company that markets GALEXOS offered excitement for the approval of it’s once a day hepatitis C treatment. Simeprevir is designed to be administered adjunctively with both ribavirin and pegylated interferon, for the treatment of acute chronic hepatitis C virus of the genotype 1 infection. As the first once daily treatment to be approved in Canada alongside ribavirin and pegylated interferon, this announcement was very well received by both patients and physicians.

As a protease inhibitor that effectually blocks the protease enzyme, Simeprevir {GALEXOS} was administered in clinical trials as a once daily oral capsule, taken for approximately 12 weeks, in conjunction with both pegylated interferon and ribavirin. Chronic hepatitis C is a complex disease that has become resistant to many current treatments. The advantage of Simeprevir is that it offers patients who have experienced failure with the use of just ribavirin and pegylated interferon a chance at a cure with the addition of this novel drug. Even if the addition of Simeprevir does not effectively “cure” the hepatitis C disease it will likely offer the patient significant symptom relief and make managing this harsh disease easier and more manageable.

Four extensive studies led to the approval of Simeprevir by Canadian Health officials, specifically the QUEST-1, QUEST-2, PROMISE and ASPIRE trials. Results from both the QUEST-1 and QUEST-2 trials indicated success in 80 percent of treatment naïve patients, with a sustained virologic response at the conclusion of 12 weeks treatment. Both the PROMISE and ASPIRE studies garnished similar results, with the vast majority of patients experiencing minimal adverse effects. Side effects reported included itching and a slight rash, increased sensitivity to the sun and constipation.

The approval of Simeprevir in Canada is essential, as over 250,000 Canadians are living with the Hepatitis C virus. Even more concerning is that almost 35 percent of people are unaware that they have the active Hepatitis C virus, and do not realize it until symptoms arise in later stages of the disease. The cases of patients with chronic hepatitis C are expected to explode in the next several decades as more people become aware of their hepatitis C status. Simeprevir is currently under a Priority Review Status by the FDA in the United States.

LGM Pharma supplies Simeprevir, CAS# 923604-59-5 for research and development purposes. Clients can be assured of quality API products and continuous support throughout the R&D process.

 

Products currently covered by valid US Patents are offered for R&D use in accordance with 35 USC 271(e)+A13(1). Any patent infringement and resulting liability is solely at buyer risk.

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