The market is booming with new drug treatments aimed at ‘curing’ Hepatitis C or at least preventing further damage to the liver and other organs. Hepatitis C, a virus that enters the body via the bloodstream and wreaks havoc without causing many external symptoms, is a progressive disease that could be fatal if left untreated. It is only after severe damage to liver (detected by specifically testing for damage) that most patients even know they have it. And while a cure does not exist, several new drugs on the market promise to ‘kill’ the virus or stop it from doing more damage.
Vertex Pharmaceutical’s (VRTX) latest drug, Incivek, developed to ‘cure’ Hepatitis C (‘cure’ simply means to stop the virus from continuing to attack the body. The virus may go into a dormant state, but will still remain in the cells), is still undergoing Phase II clinical trials to ensure its effectiveness and safety. Patients participating in the study have reported bouts of fatigue, skin rash, nausea, and headaches. These side effects are not dangerous, but the company wants to make sure to isolate these incidents and determine the causes (and hopefully tweak the drug to prevent future incidents) before submitting an application for approval by the FDA.
Companies applying for FDA approval must be very careful when submitting data from studies as review committees can reject an application for both major and minor reasons.To continue reading, click here.