Press Release: FDA Approves Accelerated Dosing Schedule for GlaxoSmithKline's Twinrix
FDA Approves Accelerated Dosing Schedule for GlaxoSmithKline's Twinrix PHILADELPHIA, April 2 -- GlaxoSmithKline announced today that the U.S. Food and Drug Administration (FDA) has approved Twinrix(R) [Hepatitis A Vaccine (Inactivated) and Hepatitis B (Recombinant) Vaccine], for an accelerated dosing schedule that consists of three doses given within three weeks followed by a booster dose at 12 months. The approval means Twinrix, the only hepatitis A and hepatitis B combination vaccine available in the United States, is now available on a dosing schedule at 0, 7, 21-30 days, followed by a booster dose at 12 months. The vaccine was first approved for adults over age 18 years by the FDA in May 2001 on a 0, 1, 6-month dosing schedule. "Hepatitis A and hepatitis B are serious liver diseases which can be prevented through vaccination," stated travel medicine specialist Bradley A. Connor, M.D., Past President, International Society of Travel Medicine and a principal study investigator. "Twinrix's new accelerated dosing schedule offers an option that could benefit individuals such as those preparing to travel internationally to high-risk areas. It may also benefit emergency first care responders, especially those deploying to disaster areas overseas, as well as others at risk for hepatitis, such as people with sexually transmitted diseases and those who are HIV positive." Many regions throughout the world are endemic for hepatitis A and hepatitis B, such as Africa, Asia, South America and parts of the Caribbean. Worldwide, approximately 1.5 million cases of hepatitis A are reported annually. In addition, hepatitis B has infected 2 billion people - one-third of the world's population. Millions of Americans travel each year to countries where hepatitis A and hepatitis B are endemic. An overwhelming majority of these international travelers are not vaccinated before the trip. Therefore, international travelers may be at risk for contracting both hepatitis A and hepatitis B. They should consult their health care provider prior to traveling abroad. The FDA approved the new dosing schedule after reviewing the safety and immune response of Twinrix given to 250 healthy adults (aged 18 years or older) at 0-, 7-, and 21- to 30-day schedule, followed by a booster dose at 12 months, compared to separate vaccinations with monovalent hepatitis A vaccine (HAVRIX at 0 and 12 months) and hepatitis B vaccine (ENGERIX-B at 0, 1, 2, and 12 months) given to 246 healthy adults as a control group. The study demonstrated that the individuals who completed the series of Twinrix on the accelerated dosing schedule had an immune response comparable to those individuals who received complete vaccination with separately administered hepatitis A and hepatitis B vaccines. About Vaccine-Preventable Hepatitis (VPH) Vaccine-Preventable Hepatitis includes hepatitis A and hepatitis B. Hepatitis C is not vaccine preventable. Hepatitis A is a serious liver disease caused by the hepatitis A virus. This virus is found in the stool of persons with hepatitis A and is spread by close personal contact and by eating food or drinking water contaminated with the hepatitis A virus. Hepatitis A can be easily passed between people within the same household. About one in five people with the disease has to be hospitalized. Hepatitis A can be fatal. Symptoms of the disease can include fever, fatigue, loss of appetite, nausea, abdominal discomfort, jaundice (yellow skin and eyes) and dark urine. Hepatitis B is a serious liver disease caused by the hepatitis B virus. The virus is passed through infected blood or body fluids. Approximately 50 percent of people with hepatitis B do not notice signs or symptoms. Those who do may experience diarrhea and vomiting, nausea, fatigue, loss of appetite, muscle and joint pain, and jaundice. Hepatitis B can cause lifelong infection, cirrhosis (scarring) of the liver, liver cancer, liver failure, and death. An estimated 1.25 million Americans are chronically infected with Hepatitis B. Estimates show that tens of thousands of people (mostly young adults) are infected each year. About Twinrix(R) As with all prescription medications, please talk with your healthcare provider to see if Twinrix is right for you. In clinical trials with Twinrix, the most common side effects included pain and redness at the injection site, headache, and tiredness. These effects were mild and did not last more than 48 hours. (See Adverse Reactions section of the Prescribing Information for Twinrix for other potential side effects.) As with any vaccine, there is a small risk of allergic reactions. If you notice any problems following vaccination, or if you are allergic to any component of the vaccine such as neomycin, yeast, or latex, please inform your healthcare provider. For more information on Twinrix visit http://www.gskvaccines.com. GlaxoSmithKline - A Leader in Vaccines GlaxoSmithKline - one of the world's leading research-based pharmaceutical and healthcare companies - is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For company information, visit GlaxoSmithKline at http://www.gsk.com. GlaxoSmithKline Forward-Looking Statements Cautionary statement regarding forward-looking statements under the safe harbor provisions of the US Private Securities Litigation Reform Act of 1995: the company cautions investors that any forward-looking statements or projections made by the company, including those made in this Announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Factors that may affect the Group's operations are described under 'Risk Factors' in the Operating and Financial Review and Prospects in the company's Annual Report 2005.