Schering-Plough wins FDA approval for hepatitis combination therapy

Mon. December 15, 2008; Posted: 09:46 AM

Dec 15, 2008 (Datamonitor via COMTEX) -- SGP | Quote | Chart | News | PowerRating -- Schering-Plough has announced that the FDA has granted marketing approval to Pegintron and Rebetol combination therapy for use in previously untreated patients three years of age and older with chronic hepatitis C.

According to the company, this represents the first and only approved Pegintron in combination with Rebetol for treating pediatric hepatitis C. Rebetol is available both as capsules and in an oral solution formulation specifically available for pediatric use.

The approval of Pegintron for the pediatric indication is based on the results of a clinical trial in 107 previously untreated patients three to 17 years of age with chronic hepatitis C and compensated liver disease.

In the pediatric population, the recommended dose of Pegintron, based on body surface area, is 60mcg/m2/week subcutaneously in combination with 15mg/kg/day of Rebetol, based on body weight, orally in two divided doses. The treatment duration for patients with HCV genotype 1 is 48 weeks and for patients with HCV genotype 2 or 3 it is 24 weeks.

Patients receiving Pegintron combination therapy (excluding those with HCV genotype 2 or 3) should be discontinued from therapy at week 12 if their HCV RNA dropped less than 2 log10 compared to pretreatment or at 24 weeks if they have detectable HCV RNA at treatment week 24, the company said.

Robert Spiegel, chief medical officer of Schering-Plough Research Institute, said: "With the FDA approval of Pegintron combination therapy for this new indication, US physicians now have access to the current standard of care for hepatitis C for use in treating their pediatric patients.

"This approval further underscores Schering-Plough's leadership and long-term commitment to developing new treatment options and innovative therapies to meet the needs of patients with hepatitis C."

http://www.datamonitor.com

Republication or redistribution, including by framing or similar means, is expressly prohibited without prior written consent. Datamonitor shall not be liable for errors or delays in the content, or for any actions taken in reliance thereon

For full details on Schering-Plough Corp (SGP) click here. Schering-Plough Corp (SGP) has Short Term PowerRatings of 6. Details on Schering-Plough Corp (SGP) Short Term PowerRatings is available at This Link.

More News: Market Updates | Stock Alerts | All Trading News | Stock Index

Archives

Feedback

Email Article Link

Close X

RELATED SITES

Please call 1-213-955-5858 ext. 1

Tax Relief Bank Levy Wage Garnishment

Disclaimer:

The Connors Group, Inc. ("Company") is not an investment advisory service, nor a registered investment advisor or broker-dealer and does not purport to tell or suggest which securities or currencies customers should buy or sell for themselves. The analysts and employees or affiliates of Company may hold positions in the stocks, currencies or industries discussed here. You understand and acknowledge that there is a very high degree of risk involved in trading securities and/or currencies. The Company, the authors, the publisher, and all affiliates of Company assume no responsibility or liability for your trading and investment results. Factual statements on the Company's website, or in its publications, are made as of the date stated and are subject to change without notice.

It should not be assumed that the methods, techniques, or indicators presented in these products will be profitable or that they will not result in losses. Past results of any individual trader or trading system published by Company are not indicative of future returns by that trader or system, and are not indicative of future returns which be realized by you. In addition, the indicators, strategies, columns, articles and all other features of Company's products (collectively, the "Information") are provided for informational and educational purposes only and should not be construed as investment advice. Examples presented on Company's website are for educational purposes only. Such set-ups are not solicitations of any order to buy or sell. Accordingly, you should not rely solely on the Information in making any investment. Rather, you should use the Information only as a starting point for doing additional independent research in order to allow you to form your own opinion regarding investments. You should always check with your licensed financial advisor and tax advisor to determine the suitability of any investment.

HYPOTHETICAL OR SIMULATED PERFORMANCE RESULTS HAVE CERTAIN INHERENT LIMITATIONS. UNLIKE AN ACTUAL PERFORMANCE RECORD, SIMULATED RESULTS DO NOT REPRESENT ACTUAL TRADING AND MAY NOT BE IMPACTED BY BROKERAGE AND OTHER SLIPPAGE FEES. ALSO, SINCE THE TRADES HAVE NOT ACTUALLY BEEN EXECUTED, THE RESULTS MAY HAVE UNDER- OR OVER-COMPENSATED FOR THE IMPACT, IF ANY, OF CERTAIN MARKET FACTORS, SUCH AS LACK OF LIQUIDITY. SIMULATED TRADING PROGRAMS IN GENERAL ARE ALSO SUBJECT TO THE FACT THAT THEY ARE DESIGNED WITH THE BENEFIT OF HINDSIGHT. NO REPRESENTATION IS BEING MADE THAT ANY ACCOUNT WILL OR IS LIKELY TO ACHIEVE PROFITS OR LOSSES SIMILAR TO THOSE SHOWN.

The Connors Group, Inc.
10 Exchange Place, Suite 1800
Jersey City, NJ 07302

All analyst commentary provided on TradingMarkets.com is provided for educational purposes only. The analysts and employees or affiliates of TradingMarkets.com may hold positions in the stocks or industries discussed here. This information is NOT a recommendation or solicitation to buy or sell any securities. Your use of this and all information contained on TradingMarkets.com is governed by the Terms and Conditions of Use. Please click the link to view those terms. Follow this link to read our Editorial Policy.