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FDA Advisory Committee Unanimously Recommends Approval of Telaprevir for People with Hepatitis C
In Phase 3 studies, telaprevir was given for 12 weeks in combination with pegylated-interferon and ribavirin (P/R) followed by P/R alone for a total of 24 weeks or 48 weeks of treatment. Data from these studies that were reviewed by the Committee showed that people who received telaprevir-based combination therapy achieved significantly higher rates of sustained viral response (SVR, or viral cure) compared to treatment with 48 weeks of P/R alone, regardless of their experience with prior treatment. Among people who were not treated previously, 79 percent achieved a viral cure with telaprevir-based combination therapy compared to 46 percent who achieved a viral cure with P/R alone.
Approximately two-thirds of people in Phase 3 studies who were not treated previously and who received telaprevir-based combination therapy were eligible to complete their treatment in six months — half the time needed with currently available medicines. Today, the FDA Committee discussed Vertex's request for the approval of response-guided therapy to allow for a six-month treatment duration for people who were not treated previously as well as for those who relapsed after prior treatment with P/R alone (prior relapsers). Side effects observed with telaprevir-based combination therapy were consistent across the Phase 3 studies. Rash and anemia occurred more frequently among those treated with telaprevir-based combination therapy compared with those who received pegylated-interferon and ribavirin alone.
"Hepatitis C is a curable disease with potentially devastating
consequences if left untreated, so we are pleased by the Committee's
unanimous recommendation to approve telaprevir for a broad group of
people with hepatitis C," said
Safety and Tolerability Information for Telaprevir
The safety profile of telaprevir has been well characterized. Data from more than 40 clinical studies across a broad group of nearly 4,000 people were included in the new drug application. The side effects observed with telaprevir-based combination therapy were consistent across the Phase 3 studies. The most common side effects, regardless of treatment arm, were fatigue, pruritus (itchiness), nausea, headache, rash, anemia, flu-like symptoms, insomnia and diarrhea with the majority being mild to moderate.
Rash and anemia occurred more frequently among those treated with telaprevir-based combination therapy. In Phase 3 studies, discontinuation of all medicines due to either rash or anemia during the telaprevir/placebo treatment phase was approximately 1 percent for rash and 1 percent for anemia. Rash was primarily characterized as eczema-like, manageable and resolved following discontinuation of telaprevir. More than 90 percent of rash was mild to moderate and investigators in the studies primarily used topical corticosteroids and/or antihistamines to treat rash. Anemia was primarily managed by reducing the dose of ribavirin.
Telaprevir is an investigational, oral inhibitor that acts directly on the hepatitis C virus protease, an enzyme essential for viral replication. More than 2,800 people with hepatitis C have received telaprevir-based combination therapy as part of Phase 2 and Phase 3 studies. The Phase 3 registration studies, ADVANCE, ILLUMINATE and REALIZE, evaluated telaprevir (750 mg, taken three times daily) in combination with Pegasys® (pegylated-interferon alfa-2a) and Copegus® (ribavirin) in people with hepatitis C who had not been treated before as well as those who were treated before but not cured with a prior treatment course of P/R.
Vertex is developing telaprevir in collaboration with Tibotec BVBA and
For complete information on the telaprevir clinical trials or a fact sheet on the trial designs visit: www.vrtx.com/press.cfm.
About Hepatitis C
Hepatitis C is a serious liver disease caused by the hepatitis C virus, which is spread through direct contact with the blood of infected people and ultimately affects the liver.i Chronic hepatitis C can lead to serious and life-threatening liver problems, including liver damage, cirrhosis, liver failure or liver cancer.i Though many people with hepatitis C may not experience symptoms, others may have symptoms such as fatigue, fever, jaundice and abdominal pain.i
Unlike HIV and hepatitis B virus, chronic hepatitis C is curable.ii However, approximately 60 percent of people who undergo treatment with an initial 48-week regimen of pegylated-interferon and ribavirin, the currently approved medicines for genotype 1 hepatitis C, do not achieve SVR,iii,iv,v or viral cure.vi If treatment is not successful and a person does not achieve a viral cure, they remain at an increased risk for progressive liver disease.vii,viii
More than 170 million people worldwide are chronically infected with
hepatitis C.vi In
PEGASYS® and COPEGUS® are registered trademarks of Hoffmann-La Roche.
Special Note Regarding Forward-Looking Statements
This press release contains forward-looking statements, including
statements regarding (i) the expectation that the
Vertex creates new possibilities in medicine. Our team aims to discover, develop and commercialize innovative therapies so people with serious diseases can lead better lives.
Vertex scientists and our collaborators are working on new medicines to cure or significantly advance the treatment of hepatitis C, cystic fibrosis, epilepsy and other life-threatening diseases.
Founded more than 20 years ago in
For more information and to view Vertex's press releases, please visit www.vrtx.com.
(VRTX - GEN)
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