U.S. FDA And Health Canada Grant Priority Reviews For Telaprevir For The Treatment Of Hepatitis C

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U.S. FDA And Health Canada Grant Priority Reviews For Telaprevir

For The Treatment Of Hepatitis C

24 Jan 2011

Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) announced that

the U.S. Food and Drug Administration (FDA) has accepted the New

Drug Application (NDA) for telaprevir and granted the company's

request for six-month Priority Review. Telaprevir is Vertex's lead

medicine in development for people with genotype 1 chronic hepatitis

C. The FDA grants Priority Review to medicines that offer major

advances in treatment or provide a treatment where no adequate

therapy exists. A target review date of May 23, 2011 is set under

the Prescription Drug User Fee Act (PDUFA) for the FDA's approval

decision, which is four months earlier than the standard review time

of 10 months.

Additionally, Vertex today announced the completion of a New Drug

Submission (NDS) to the Therapeutic Product Directorate (TPD) of

Health Canada seeking approval for telaprevir in Canada. Telaprevir

was also granted Priority Review in Canada, which allows for faster

review for promising medicines that address life-threatening or

severely debilitating conditions and for which there are few

effective therapies already available. Standard review in Canada

takes 18 months or more and Priority Review typically shortens the

review time to approximately six to nine months.

In December 2010, Janssen-Cilag International NV announced that the

European Medicines Agency (EMA) accepted telaprevir for accelerated

assessment in Europe, which is granted to new medicines of major

public health interest.

"Data from Phase 3 studies showed that when compared to currently

available medicines, telaprevir-based combination therapy nearly

doubled viral cure rates and cut treatment time in half for the

majority of patients new to treatment," said Mueller, Ph.D.,

Chief Scientific Officer and Executive Vice President of Global

Research and Development at Vertex. "We look forward to working with

the FDA and Health Canada to make telaprevir available as quickly as

possible for people with hepatitis C."

Data to Support the Telaprevir Submissions

The regulatory submissions in the United States, Canada and Europe

are supported by data from three Phase 3 studies, known as ADVANCE,

ILLUMINATE and REALIZE, which evaluated up to 12 weeks of telaprevir

in combination with Pegasys® (pegylated-interferon alfa-2a) and

Copegus® (ribavirin) in people chronically infected with genotype 1

hepatitis C virus (HCV) who were new to treatment as well as those

who were treated before with currently available medicines but did

not achieve a sustained viral response (SVR, or viral cure). In

these studies, treatment with telaprevir-based combination therapy

resulted in significantly higher viral cure rates compared to

approved medicines, regardless of prior treatment experience, race

or stage of liver disease. Up to 75 percent of people new to

treatment achieved a viral cure with telaprevir-based therapy. The

majority of these people were able to complete their course of

treatment at six months - half the time needed with currently

available medicines. Among those who did not achieve a viral cure

with a prior treatment course of currently available medicines,

Phase 3 data showed that telaprevir-based combination therapy

resulted in viral cure rates three to five times higher compared to

re-treatment with currently available medicines. The safety and

tolerability results of telaprevir-based combination therapy were

consistent across the Phase 3 studies. The most common adverse

events regardless of treatment regimen were rash, fatigue, pruritis,

headache, nausea, anemia, insomnia, diarrhea, flu-like symptoms and

pyrexia, with the majority being mild or moderate in severity.

Vertex provided a summary of Phase 3 results, including SVR and

safety data for telaprevir, in its November 23, 2010 press release

announcing the NDA submission.

About Telaprevir

Telaprevir is an investigational, oral inhibitor that acts directly

on the HCV protease, an enzyme essential for viral replication. To

date, more than 2,500 people with genotype 1 hepatitis C have

received telaprevir in Phase 2 and Phase 3 studies.

Vertex is developing telaprevir in collaboration with Tibotec BVBA

and Mitsubishi Tanabe Pharma. Vertex has rights to commercialize

telaprevir in North America. Through its affiliate, Janssen, Tibotec

has rights to commercialize telaprevir in Europe, South America,

Australia, the Middle East and certain other countries. Mitsubishi

Tanabe Pharma has rights to commercialize telaprevir in Japan and

certain Far East countries.

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.1 Chronic hepatitis

C can lead to serious and life-threatening liver problems, including

liver damage, cirrhosis, liver failure or liver cancer.1 Though many

people with hepatitis C may not experience symptoms, others may have

symptoms such as fatigue, fever, jaundice and abdominal pain.1

Approximately 60 percent of genotype 1 patients who undergo an

initial 48-week regimen with pegylated-interferon and ribavirin, the

currently approved medicines, do not achieve SVR,2,3,4 or viral

cure.5 If treatment is not successful and a person does not achieve

a viral cure, they remain at an increased risk for progressive liver

disease.6,7,8.9,10

Hepatitis C in the United States

Up to 3.9 million people in the United States have chronic hepatitis

C and 75 percent of them are unaware of their infection.11 The

majority of people with hepatitis C in the U.S. were born between

1946 and 1964, accounting for two of every three people with chronic

hepatitis C.10 Hepatitis C is the leading cause of liver

transplantations in the U.S. and is reported to contribute to 4,600

to 12,000 deaths annually.7 By 2029, total annual medical costs in

the U.S. for people with hepatitis C are expected to more than

double, from $30 billion in 2009 to approximately $85 billion.10

Hepatitis C in Canada

Approximately 250,000 people in Canada have chronic hepatitis C and

more than a third of them do not know they are infected.12 Three

provinces account for 80 percent of hepatitis C infections in

Canada: Ontario (42 percent), British Columbia (22 percent) and

Quebec (16 percent).13 Each year up to 5,000 people are newly

infected with hepatitis C and in 2007 alone, nearly 8,000 people

were infected.12, 13 In 2010, the annual cost of hepatitis C due to

medical treatment and lost productivity in Canada was estimated to

reach $1 billion.14 By 2022, the number of hepatitis C-related

deaths is expected to increase by one-third.15

References:

1. Centers for Disease Control and Prevention. Hepatitis C Fact

Sheet: CDC Viral Hepatitis. Available here. Accessed May 25, 2010.

2. Manns MP, McHutchison JG, Gordon SC, et al. Peginterferon

alfa-2b plus ribavirin compared with interferon alfa-2b plus

ribavirin for initial treatment of chronic hepatitis C: a randomised

trial. Lancet. 2001;358:958-965.

3. Fried MW, Shiffman ML, Reddy KR, et al. Peginterferon

alfa-2a plus ribavirin for chronic hepatitis C virus infection. N

Engl J Med. 2002;347:975-982.

4. McHutchison JG, Lawitz EJ, Shiffman ML, et al; IDEAL Study Team.

Peginterferon alfa-2b or alfa-2a with ribavirin for treatment of

hepatitis C infection. N Engl J Med. 2009;361:580-593.

5. Ghany MG, Strader DB, DL, Seeff, LB. Diagnosis, management

and treatment of hepatitis C; An update. Hepatology. 2009;49

(4):1-40.

6. TR, Ghany MG, Kim HY, Snow KK, K, Lok AS. Outcome

of sustained virological responders and non-responders in the

Hepatitis C Antiviral Long-Term Treatment Against Cirrhosis (HALT-C)

trial. Hepatology. 2008;50(Suppl 4):357A (Abstract 115).

7 GL, Alter MJ, El-Serag H, Poynard T, Jennings LW. Aging of

hepatitis C virus (HCV)-infected persons in the United States: A

multiple cohort model of HCV prevalence and disease progression.

Gastroenterology. 2010;138:513-521.

8 Volk MI, Tocco R, Saini S, Lok, ASF. Public health impact of

antiviral therapy for hepatitis C in the United States. Hepatology.

2009;50(6):1750-1755.

9 Veldt BJ, Heathcote J, Wedmeyer H. Sustained virologic response

and clinical outcomes in patients with chronic hepatitis C and

advanced fibrosis. ls of Internal Medicine. 2007; 147:

677-684.

10 Pyenson B, Fitch K, Iwasaki K. Consequences of hepatitis C virus

(HCV): Costs of a baby boomer epidemic of liver disease. See here. Updated May 2009. This report was

commissioned by Vertex Pharmaceuticals, Inc.

11. Institute of Medicine of the National Academies. Hepatitis and

liver cancer: a national strategy for prevention and control of

hepatitis B and C. Colvin HM and AE, ed. See here. Updated January 11,

2010. Accessed May 25, 2010.

12. Public Health Agency of Canada. Hepatitis C: Get the facts. You

could have it and not know it. See here. Updated September 21,

2010. Accessed January 18, 2011.

13. Public Health Agency of Canada. Modeling the incidence of

prevalence of hepatitis C infection and its sequelae in Canada,

2007. See here. Updated October 20,

2010. Accessed January 18, 2011.

14. Public Health Agency of Canada. A renewed public health response

to address hepatitis C: A summary report of the priority-setting

process and strategic framework to action. See here. Updated June 2009.

Accessed January 2011.

15. Sherman M, Sharfran S, Burak K, et al. Management of

chronic hepatitis C consensus guidelines. Can J Gastroenterol.

2007;21 (Suppl C):25C-34C.

Source:

Vertex

Article URL: http://www.medicalnewstoday.com/articles/214475.php

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Bill Eastman

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