EU medicines agency backs new drugs from J&J, others
Fri Jul 22, 2011 1:11pm GMT
LONDON, July 22 (Reuters) - European Medicines Agency statement following monthly meeting of Committee for Medicinal Products for Human Use (CHMP).
Positive opinions recommending the granting of a marketing authorisation, for the following medicines:
* Dexdor (dexmedetomidine), from Orion Corporation, intended for sedation of adult intensive care unit (ICU) patients.
* Incivo (telaprevir), from Janssen-Cilag International N.V., intended for the treatment of genotype 1 chronic hepatitis C in adult patients with compensated liver disease.
* Plenadren (hydrocortisone), an orphan medicine from DuoCort Pharma AB, intended for the treatment of adrenal insufficiency in adults.
* Vyndaqel (tafamidis), from Pfizer Specialty UK Ltd, an orphan medicine intended for the treatment of transthyretin amyloidosis in adult patients with symptomatic polyneuropathy, a severe, progressive orphan disease.
* Zytiga (abiraterone acetate), from Janssen-Cilag International N.V., intended in combination with prednisone or prednisolone for the treatment of metastatic castration resistant prostate cancer in adult men whose disease has progressed on or after a docetaxel-based chemotherapy regimen.
Positive opinions for applications for extension of indication:
* Afinitor (everolimus), from Novartis Europharm Ltd, to include treatment of patients with unresectable or metastatic, well- or moderately differentiated neuroendocrine tumours of pancreatic origin in adults with progressive disease.
* Enbrel (etanercept), from Wyeth Europa Ltd, to extend the lower age range in polyarticular juvenile idiopathic arthritis (JIA) from four to two years; and to extend the lower age range in paediatric plaque psoriasis from eight to six years.
* Tarceva (erlotinib), from Roche Registration Ltd, to include first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer with EGFR activating mutations. (Reporting by Ben Hirschler)
INCIVO(R) Receives Positive Opinion From the Committee for Medicinal Products for Human use (CHMP) for the Treatment of Genotype-1 Hepatitis C Virus (HCV)
BEERSE, Belgium, July 22, 2011 /PRNewswire/ --
- Expanding New Treatment Class for Patients With HCV -
Tibotec Virco-Virology BVBA, one of the Janssen Pharmaceutical Companies, announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending the approval of INCIVO (telaprevir), a direct acting antiviral (DAA) for the treatment of chronic genotype-1 hepatitis C virus (HCV), in combination with pegylated-interferon and ribavirin, the previously accepted standard of care.
The CHMP positive opinion is based on results from three phase III clinical trials, ADVANCE[1], REALIZE[2] and ILLUMINATE[3] which evaluated the efficacy and safety of telaprevir in combination with pegylated-interferon and ribavirin in more than 2,290 treatment-naïve and previously-treated genotype 1 HCV patients.[1,2,3] Data from ADVANCE and REALIZE were published in the 23rd June edition of the New England Journal of Medicine. Data from the ILLUMINATE study were presented at the 61st annual meeting of the American Association for the Study of Liver Diseases in 2010.
The CHMP positive opinion is a critical step in the approval process and will be considered by the European Commission, which has authority to approve medicines for use throughout the European Union. Telaprevir was approved by the U.S. Food and Drug Administration (FDA) in May 2011 and is marketed by Vertex Pharmaceuticals under the brand name INCIVEK[TM]. Following marketing authorization approvals, telaprevir will be marketed in the EU and certain other global territories under the brand name INCIVO by the Janssen Companies.
"We are encouraged by this positive decision from the CHMP and will continue to work closely with other regulatory authorities to make telaprevir available for people with HCV. If approved by the European Commission, the addition of telaprevir will offer patients an improved treatment option compared to the previously accepted standard of care, which only cures 40-50 percent of genotype 1 patients," said Ramon Polo, INCIVO Compound Development Team Leader. "Telaprevir is part of Janssen's expanding infectious disease portfolio, which is comprised of innovative therapies in HIV/AIDS, tuberculosis and now HCV that are helping to redefine and improve treatment outcomes. Janssen remains dedicated to improving the lives of patients and supporting healthcare professionals around the world."
About INCIVO
INCIVO is being developed by Tibotec, one of the Janssen Pharmaceutical Companies, in collaboration with Vertex Pharmaceuticals and Mitsubishi Tanabe Pharma. The Janssen Companies have the right to commercialize telaprevir in Europe, Latin America, the Middle East, Africa, India, Australia and New Zealand under the commercial name INCIVO®; Vertex has the right to commercialize telaprevir in North America under the name INCIVEK™; Mitsubishi Tanabe Pharma has the right to commercialize telaprevir in Japan and certain Far Eastern countries.
On May 23rd 2011, US FDA approved telaprevir for the treatment of people with chronic genotype 1 hepatitis C with compensated liver disease.
About HCV
HCV is a blood-borne infectious disease that affects the liver.[4] With an estimated 170 million people infected worldwide, and three to four million people newly infected each year,[5] HCV puts a significant burden on patients and society. Chronic infection with HCV can lead to liver cancer and other serious and fatal liver diseases, and is the most common cause of liver transplant in Europe.[6] The previously accepted standard of treatment for HCV is pegylated-interferon combined with ribavirin,[7] however this only cures 40-50 percent of genotype 1 patients.[8]
About Tibotec
Tibotec Virco-Virology BVBA, one of the Janssen Pharmaceutical Companies of Johnson & Johnson, is a global pharmaceutical and research development company. The Company's main research and development facilities are in Beerse, Belgium with offices in Titusville, NJ and Cork, Ireland. Tibotec is dedicated to the discovery and development of innovative HIV/AIDS and hepatitis C drugs, and anti-infectives for diseases of high unmet medical need.
About Janssen
The Janssen Pharmaceutical Companies of Johnson & Johnson are dedicated to addressing and solving the most important unmet medical needs of our time, including oncology , immunology, neuroscience, infectious disease, and cardiovascular and metabolic diseases.
Driven by our commitment to patients, we develop innovative products, services and healthcare solutions to help people throughout the world.
More information can be found at http://www.janssen-emea.com
This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Tibotec Virco-Virology BVBA, any of the other Janssen Pharmaceutical Companies and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to, general industry conditions and competition; economic factors, such as interest rate and currency exchange rate fluctuations; technological advances and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approvals; domestic and foreign health care reforms and governmental laws and regulations; trends toward health care cost containment; and increased scrutiny of the healthcare industry by government agencies. A further list and description of these risks, uncertainties and other factors can be found in Exhibit 99 of Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended January 2, 2011. Copies of this Form 10-K, as well as subsequent filings, are available online at http://www.sec.gov, http://www.jnj.com or on request from Johnson & Johnson. TheJanssen Pharmaceutical Companies and Johnson & Johnson do not undertake to update any forward-looking statements as a result of new information or future events or developments.
References:
John G et al. Telaprevir in Combination with Peginterferon and Ribavirin in Genotype 1 HCV Treatment-Naïve Patients: Final Results of Phase 3 ADVANCE study. Paper presented at: The Liver Meeting of the American Association for the Study of Liver Diseases (AASLD); 2010.
Zeuzem S, Andreone P, Pol S et al. REALIZE trial final results: telaprevir-based regimen for genotype 1 hepatitis C virus infection in patients with prior response, partial response or relapse to peginterferon/ribavirin. Paper presented at: 46th annual meeting of the European Association for the Study of the Liver (EASL); 2011.
Sherman KE et al. Telaprevir in Combination with Peginterferon Alfa2a and Ribavirin for 24 or 48 weeks in Treatment-Naive Genotype 1 HCV Patients who Achieved an Extended Rapid Viral Response: Final Results of Phase 3 ILLUMINATE Study. Paper presented at: The Liver Meeting of the American Association for the Study of Liver Diseases (AASLD); 2010.
Centres for Disease Control and Prevention. Hepatitis C FAQs. [cited 2009 Dec 17] Available from: http://www.cdc.gov/hepatitis/C/cFAQ.htm#transmission.
World Health Organization. Hepatitis C. Weekly Epidemiological Record. 1997;72:65-69.
The Hepatitis C Trust. Treatments: Potential New Drugs. [cited 2010 Feb 20] Available from: http://www.hepctrust.org.uk/Treatment/Potential+New+Drugs/Drugs+that+target+the+virus.htm.
McHutchison J. et al. Peginterferon Alfa-2b or Alfa-2a with Ribavirin for Treatment of Hepatitis C Infection. N Engl J Med. 2009; 361: 580-93.
Simin M et al. Cochrane systematic review: pegylated interferon plus ribavirin vs. interferon plus ribavirin for chronic hepatitis C. Alimentary Pharmacology & Therapeutics. 2007; 25(10):1153-62.
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