14th Nov 2007 17:22
GlaxoSmithKline PLC14 November 2007 GSK Revises US Labeling for Avandia(R) November 14, 2007 - London & Philadelphia - GlaxoSmithKline announced today thatit is implementing changes to the US product label for Avandia(R) (rosiglitazonemaleate), based on an extensive and thorough review by the FDA of myocardialischemia data on Avandia, the most widely studied oral anti-diabetic medicineavailable. The boxed warning has been revised to add the FDA's conclusion that, while anFDA meta-analysis of short-term studies - mostly against placebo - showed anassociation between Avandia and an increase in myocardial ischemic events, thatrisk was not confirmed or excluded in three long-term clinical trials comparingAvandia against both placebo and other oral anti-diabetes medicines. The boxwill state that the available data on the risk of myocardial ischemia areinconclusive. The FDA has also concluded there is insufficient information available todetermine whether any oral anti-diabetic medicine reduces cardiovascular risk.The FDA has directed that the sentence - "There have been no clinical studiesestablishing conclusive evidence of macrovascular risk reduction with Avandia orany other oral antidiabetic drugs" - will be added as a warning on the labels ofall oral anti-diabetic medicines. The Avandia label also has been updated to add that Avandia is not recommended -though not contraindicated - for use with patients who are taking insulin ornitrates. The label summarizes the data on myocardial ischemia to help doctorscontinue to evaluate which patients could benefit from taking Avandia, and thosefor whom alternative treatment should be considered. The changes are now included in labeling for Avandia, and will be incorporatedinto future revised labeling for all approved rosiglitazone-containing products,including Avandamet (rosiglitazone maleate and metformin hydrochloride), andAvandaryl (rosiglitazone maleate and glimepiride). GSK is also preparing aMedication Guide to help educate patients about potential benefits and risks andto provide other information on Avandia. "Avandia remains a safe and effective medicine for most patients with type 2diabetes when used appropriately," said Dr. Ronald Krall, GSK Chief MedicalOfficer. "Given the severity of this disease and the importance of Avandia inhelping patients manage their diabetes, we will continue to work with the FDA toconduct more studies about the safety and benefits of our medicine." As previously stated by GSK, two long-term trials in diabetic patients comparingAvandia to other oral anti-diabetic medicines show no increased risk forcardiovascular events compared to other commonly used medications, other thanthe well-known risk of congestive heart failure with TZDs. One trial - ADOPT -shows no increased myocardial ischemic risk compared to metformin orsulfonylurea. The interim results of a second long-term trial - RECORD - alsoshow no increased risk of major cardiovascular events (death, heart attack andstroke) between Avandia and other medications; however, firm conclusions cannotbe drawn because the trial has not yet been completed. The updated labelincludes data from ADOPT and RECORD plus a third long-term trial in pre-diabeticpatients (DREAM) which show there was no increased risk of Avandia overcomparators with regard to myocardial infarction, mortality, or other non-heartfailure cardiovascular events. GSK believes data from ongoing and future clinical trials will provideadditional scientific support for both the benefit and safety of Avandia. GSKhas agreed to work with the FDA to plan and carry out a clinical trial tofurther investigate the cardiovascular effects of Avandia. Avandia has been prescribed to more than seven million people over the lastseven years to help them control their blood sugar levels. Importantly, Avandiahas been shown to control blood sugar for longer than the most commonly usedoral anti-diabetic medicines - up to five years. Long-term glycemic control isimportant to help prevent the serious complications of diabetes, especiallymicrovascular complications leading to blindness, amputation and kidney failure.Avandia is an important treatment option for physicians, since two-thirds ofdiabetic patients suffer with uncontrolled disease and many require two or threemedicines to maintain their blood sugar. GlaxoSmithKline - one of the world's leading research-based pharmaceutical andhealthcare companies - is committed to improving the quality of human life byenabling people to do more, feel better and live longer. For companyinformation, visit GlaxoSmithKline on the World Wide Web at www.gsk.com. S M BicknellCompany Secretary14th November 2007 Important Safety Information for Avandia(R) (rosiglitazone maleate) Avandia, along with diet and exercise, helps improve blood sugar control inpatients with type 2 diabetes. Avandia can cause or worsen heart failure. If you have severe heart failure(very poor pumping ability of the heart), you cannot be started on Avandia.Avandia is also not recommended if you have heart failure with symptoms (such asshortness of breath or swelling) even if these symptoms are not severe. Avandia may increase your risk of other heart problems that occur when there isreduced blood flow to the heart, such as chest pain (angina) or heart attack(myocardial infarction). This risk appeared higher in patients taking medicinescalled nitrates or insulin. Taking Avandia with insulin or with nitrates is notrecommended. If you have chest pain or a feeling of chest pressure, you should seek immediatemedical attention, regardless of what diabetes medicines you are taking. If you take Avandia, tell your doctor right away if you: • Have swollen legs or ankles, a rapid increase in weight or difficulty breathing, or unusual tiredness • Experience changes in vision • Become pregnant Review your medical history and tell your doctor if you: • Have heart failure or other heart problems • Have liver problems or liver disease • Are pregnant or are nursing Women taking Avandia should know that Avandia may increase the risk ofpregnancy. More fractures have been observed in women taking Avandia. For more information about Avandia, please see Patient Information. For furtherinformation on Avandia, please see full Prescribing Information. Cautionary statement regarding forward-looking statements Under the safe harbor provisions of the US Private Securities Litigation ReformAct of 1995, the company cautions investors that any forward-looking statementsor projections made by the company, including those made in this Announcement,are subject to risks and uncertainties that may cause actual results to differmaterially from those projected. Factors that may affect the company'soperations are described under 'Risk Factors' in the 'Business Review' in thecompany's Annual Report 2006. Inquiries US Media inquiries: Nancy Pekarek (215) 751 7709 Mary Anne Rhyne (919) 483 2839 UK Media inquiries: Phil Thomson (020) 8047 5502 Alice Hunt (020) 8047 5502 Joss Mathieson (020) 8047 5502 Claire Brough (020) 8047 5502 US Analyst/ Investor inquiries: Frank Murdolo (215) 751 7002 Tom Curry (215) 751 5419 European Analyst/Investor inquiries: David Mawdsley (020) 8047 5564 Sally Ferguson (020) 8047 5543 This information is provided by RNS The company news service from the London Stock ExchangeRelated Shares:
Glaxosmithkline