FDA approves Tekturna HCT® as initial treatment in patients unlikely
to achieve their blood pressure
FDA approves Tekturna HCT® as initial treatment in patients unlikely to achieve their blood pressure goal with a single agent
(Thomson Reuters ONE) - Corporate news announcement processed and transmitted by Hugin AS.The issuer is solely responsible for the content of this announcement. ------------------------------------------------------------------------------------ * Tekturna HCT combines the only approved direct renin inhibitor, Tekturna®, with widely used diuretic, hydrochlorothiazide, in a single pill[1] * Data show combination of Tekturna and hydrochlorothiazide resulted in significant additional blood pressure reductions compared to either drug alone[1] * Up to 85% of patients may require multiple medications to help control their blood pressure, underscoring the need for more effective combination treatments[2],[3] * US guidelines recommend consideration for combination therapy as first-line therapy in patients unlikely to get to goal with a single agent[4]Basel, July 21, 2009 - The US Food and Drug Administration (FDA) hasapproved Tekturna HCT® (aliskiren and hydrochlorothiazide) tablets asinitial therapy for patients who are likely to need multiple drugs toachieve their blood pressure goals. Tekturna HCT is a single-pillcombination of Tekturna® (aliskiren), the first and only approveddirect renin inhibitor[1], and the diuretic hydrochlorothiazide(HCTZ), one of the most commonly used high blood pressuremedications[5].The FDA approval of Tekturna HCT as initial therapy was based onclinical trial data involving more than 2,700 patients, which showedthat treatment with the combination of Tekturna and HCTZ offeredgreater blood pressure reductions than either drug alone[1]."Up to 85% of patients will need more than one medication to reachtheir blood pressure goals," said Dr. Alan Gradman, Cardiologist atThe Western Pennsylvania Hospital and Professor of Medicine at TempleUniversity. "This approval gives doctors the opportunity toaggressively treat their patients with a single-pill combination ofthe only approved drug, Tekturna, that works by directly targetingrenin and decreasing the activity of the renin angiotensinaldosterone system (RAAS) and, HCTZ, a diuretic. This results in moresignificant blood pressure reductions, compared to taking either drugalone."High blood pressure affects nearly one billion individualsglobally[4] and is a major risk factor for cardiovascular disease,the number one leading cause of death worldwide[6]. If leftuntreated, patients with high blood pressure are at risk ofcardiovascular events such as stroke, heart attack and heart failure,and of organ damage including kidney failure and vision problems[4].Up to 65% of patients with high blood pressure do not have thecondition under control[7].Current US treatment guidelines support the first-line use ofcombination therapy in appropriate high blood pressure patients. TheSeventh Report of the Joint National Committee on Prevention,Detection, Evaluation, and Treatment of High Blood Pressure (JNC7)recommends that physicians consider starting their high bloodpressure patients with two treatment agents, one of which should be adiuretic, if blood pressure is >20/10 mmHg above goal4. The use ofmultiple medications may help patients achieve blood pressure goalsin a more timely fashion[4]."We are very pleased the FDA recognizes the benefit of Tekturna HCTfor the first-line treatment of patients with moderately high bloodpressure," said Trevor Mundel, MD, Global Head of Development atNovartis Pharma AG. "Novartis is committed to supporting the researchand development of effective treatments for high blood pressure thatwill help patients reach their blood pressure treatment goals."About Rasilez/TekturnaTekturna, a direct renin-inhibitor, is the only drug that works bydirectly targeting renin to decrease the activity of the RAAS[1].Renin is an enzyme produced by the kidneys that starts a process thatnarrows blood vessels and, when inappropriately activated, may leadto high blood pressure. Tekturna reduces renin activity and helpsblood vessels relax and widen so blood pressure is lowered[1].Diuretics work to lower blood pressure by removing excess water andsalt from the body[1].The heart and kidney protection potential of Rasilez/Tekturna,independent of its blood pressure lowering ability, is currentlybeing investigated further in the landmark ASPIRE HIGHER program, thelargest ongoing cardio-renal outcomes program worldwide involvingmore than 35,000 patients in 14 trials.Rasilez/Tekturna is approved in over 70 countries. Tekturna wasapproved in the US in March 2007 and in the European Union in August2007 under the trade name Rasilez. In July 2009, Rasilez alsoreceived approval in Japan. Tekturna HCT, the first single-pillcombination involving Tekturna, was approved in the US in January2008 for second-line treatment of high blood pressure. Thesingle-pill combination Rasilez HCT was approved in the EuropeanUnion in January 2009. Other single-pill combinations with Rasilezare currently in development including a combination with Diovan anda single pill combination with amlodipine.Novartis is focused on improving the lives of the hundreds ofthousands of people with cardiovascular and metabolic diseases. As aglobal leader in cardiovascular and metabolic health for nearly 50years, Novartis provides innovative therapies and support programs totreat high blood pressure and diabetes - both major public healthissues. The portfolio includes the world's most-prescribedangiotensin receptor blocker, the first and only approved directrenin inhibitor, a single pill combining two leading high bloodpressure medicines, and a DPP-4 inhibitor.Tekturna HCT is available in four strengths as tablets containingaliskiren and hydrochlorothiazide: 150 mg/12.5 mg tablets, 150 mg/25mg tablets, 300 mg/12.5 mg tablets and 300 mg/25 mg tablets[1].Study DetailsThe FDA approvals of Tekturna HCT were based on a clinical trialprogram involving over 6,200 patients and evaluated more than 2,700patients exposed to combinations of Tekturna and hydrochlorothiazide.The safety and efficacy of Tekturna HCT were evaluated in patientswith mild-to-moderate hypertension in an eight-week, randomized,double-blind, placebo-controlled, parallel-group, 15-arm factorialtrial (n=2762). Patients were randomized to receive variouscombinations of Tekturna (75 mg to 300 mg) plus hydrochlorothiazide(6.25 mg to 25 mg) once daily (without titrating up from monotherapy)and followed for blood pressure response. The combination of Tekturnaand hydrochlorothiazide resulted in additive placebo-adjusteddecreases in systolic and diastolic blood pressure at trough of10-14/5-7 mmHg at doses of 150-300 mg/12.5-25 mg, compared to 5-8/2-3mmHg for Tekturna 150 mg to 300 mg and 6-7/2-3 mmHg forhydrochlorothiazide 12.5 mg to 25 mg alone. Blood pressure reductionswith the combinations were greater than the reductions with themonotherapies. The safety and efficacy of Tekturna HCT as initialtherapy was evaluated in this trial. All patients randomized to thecombination groups received the combination treatment of Tekturna HCTat assigned doses as initial therapy without titration frommonotherapy. The antihypertensive effect of Tekturna HCT was largelymanifested within one week. The maximum antihypertensive effect wasgenerally attained after about four weeks of therapy.DisclaimerThe foregoing release contains forward-looking statements that can beidentified by terminology such as "may," "risk," "committed," "will,""potential," or similar expressions, or by express or implieddiscussions regarding potential future indications or labelling forRasilez/Tekturna or Tekturna HCT, or regarding potential futurerevenues from Rasilez/Tekturna or Tekturna HCT. You should not placeundue reliance on these statements. Such forward-looking statementsreflect the current views of management regarding future events, andinvolve known and unknown risks, uncertainties and other factors thatmay cause actual results with Rasilez/Tekturna or Tekturna HCT to bematerially different from any future results, performance orachievements expressed or implied by such statements. There can be noguarantee that Rasilez/Tekturna or Tekturna HCT will be approved forany additional indications or labelling. Nor can there be anyguarantee that Rasilez/Tekturna or Tekturna HCT will achieve anyparticular levels of revenue in the future. In particular,management's expectations regarding Rasilez/Tekturna or Tekturna HCTcould be affected by, among other things, unexpected clinical trialresults, including unexpected new clinical data and unexpectedadditional analysis of existing clinical data; the company's abilityto obtain or maintain patent or other proprietary intellectualproperty protection; competition in general; unexpected regulatoryactions or delays or government regulation generally; government,industry and general public pricing pressures; the impact that theforegoing factors could have on the values attributed to the NovartisGroup's assets and liabilities as recorded in the Group'sconsolidated balance sheet, and other risks and factors referred toin Novartis AG's current Form 20-F on file with the US Securities andExchange Commission. Should one or more of these risks oruncertainties materialize, or should underlying assumptions proveincorrect, actual results may vary materially from those anticipated,believed, estimated or expected. Novartis is providing theinformation in this press release as of this date and does notundertake any obligation to update any forward-looking statementscontained in this press release as a result of new information,future events or otherwise.About NovartisNovartis provides healthcare solutions that address the evolvingneeds of patients and societies. Focused solely on healthcare,Novartis offers a diversified portfolio to best meet these needs:innovative medicines, cost-saving generic pharmaceuticals, preventivevaccines, diagnostic tools and consumer health products. Novartis isthe only company with leading positions in these areas. In 2008, theGroup's continuing operations achieved net sales of USD 41.5 billionand net income of USD 8.2 billion. Approximately USD 7.2 billion wasinvested in R&D activities throughout the Group. Headquartered inBasel, Switzerland, Novartis Group companies employ approximately99,000 full-time-equivalent associates and operate in more than 140countries around the world. For more information, please visithttp://www.novartis.com.References1. Tekturna HCT Annotated Initial Therapy DRAFT Label. September2008.2. Pepine CJ, Handberg EM, Cooper-DeHoff RM, et al. A calciumantagonist vs. a non-calcium antagonist hypertension treatmentstrategy for patients with coronary artery disease. The InternationalVerapamil-Trandolapril Study (INVEST): a randomized controlled trial.JAMA. 2003;290:2805-2816.3. Dahlof B, et al. Cardiovascular morbidity and mortality in theLosartan intervention for endpoint reduction in hypertension study(LIFE): a randomised trial against atenolol. Lancet.2002;359:995-1003.4. Chobanian AV, Bakris GL, Black HR, et al. and the National HighBlood Pressure Education Program Coordinating Committee. The seventhreport of the Joint National Committee on prevention, detection,evaluation, and treatment of high blood pressure. NIH Publication No.04-5230. August 2004.5. Messerli FH and Sripal Bangalore, MD. Antihypertensive Efficacy ofAliskiren. Circulation. 2009; 119: 373-373.6. World Health Organization. Cardiovascular disease factsheet.Available at:http://www.who.int/mediacentre/factsheets/fs317/en/index.html. Lastaccessed April 2009.7. Rosamond W et al. Heart disease and stroke statistics 2008 update:a report from the American Heart Association Statistics Committee andStroke Statistics Subcommittee. Circulation 2008;117:e25-e146. # # #Novartis Media RelationsCentral media line : +41 61 324 2200Eric Althoff Yanyan ChangNovartis Global Media Relations Novartis Pharma Communications+41 61 324 7999 (direct) + 41 61 324 2339 (direct)+41 79 593 4202 (mobile) + 41 79 292 0959 (mobile)eric.althoff(at)novartis.com yanyan.chang(at)novartis.come-mail: media.relations(at)novartis.comNovartis Investor RelationsCentral phone: +41 61 324 7944Ruth Metzler-Arnold +41 61 324 North America: 9980Pierre-Michel Bringer +41 61 324 Richard Jarvis +1 212 830 1065 2433John Gilardi +41 61 324 Jill Pozarek +1 212 830 3018 2445Thomas Hungerbuehler +41 61 324 Edwin Valeriano +1 212 830 8425 2456Isabella Zinck +41 61 324 7188e-mail: e-mail:investor.relations(at)novartis.com investor.relations(at)novartis.comhttp://hugin.info/134323/R/1329924/314153.pdf --- End of Message ---Novartis International AGPosfach Basel WKN: 904278; ISIN: CH0012005267; Index: SLCI, SMI, SPI, SLIFE;Listed: Main Market in SIX Swiss Exchange, ZLS in BX Berne eXchange;
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Datum: 21.07.2009 - 07:15 Uhr
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