La Food and Drug Administration approuve le Truvada de GILEAD, une co-formulation à dose fixe du Viread et de l'Emtriva à prendre une fois par jour dans le cadre d'un traitement combiné du VIH.
Presse économique / Santé / Médecine
BIOWIRE2K
FOSTER CITY, Calif.--(BUSINESS WIRE)—2 Août 2004--
C'est le troisième agent de traitement du VIH et le quatrième agent antiviral de Gilead approuvé en trois ans. Le Truvada est également disponible dans le cadre du programme de Gilead en faveur des pays en voie de développement.
Gilead Sciences (Nasdaq: GILD) a annoncé ce jour que la FDA (Food and Drug Administration) a donné son approbation dans le cadre d'une procédure accélérée pour le Truvada(TM) (emtricitabine and tenofovir disoproxil fumarate) a
fixed-dose combination of the company's anti-HIV medications
Emtriva(R) (emtricitabine) and Viread(R) (tenofovir disoproxil
fumarate). Truvada combines 200 mg of emtricitabine and 300 mg of
tenofovir disoproxil fumarate in one tablet, taken once a day in
combination with other antiretroviral agents.
( BW)(CA-GILEAD-SCIENCES)(GILD) U.S. FDA Approves Gilead's Truvada, aOne-Tablet, Once-a-Day Fixed-Dose Co-Formulation of Viread and Emtrivaas Part of HIV Combination Therapy
Business Editors/Health/Medical Writers
BIOWIRE2K
FOSTER CITY, Calif.--(BUSINESS WIRE)--Aug. 2, 2004—
Gilead's Third HIV Therapeutic and Fourth Antiviral Approved in Three Years; Truvada Also Available Through Gilead Access Program for Developing World
Gilead Sciences (Nasdaq: GILD) today announced that the U.S. Foodand Drug Administration (FDA) has granted accelerated approval ofTruvada(TM) (emtricitabine and tenofovir disoproxil fumarate) afixed-dose combination of the company's anti-HIV medicationsEmtriva(R) (emtricitabine) and Viread(R) (tenofovir disoproxilfumarate). Truvada combines 200 mg of emtricitabine and 300 mg oftenofovir disoproxil fumarate in one tablet, taken once a day incombination with other antiretroviral agents. The detailed indicationand important safety information for Truvada are highlighted below.Truvada is Gilead's third once-a-day HIV therapeutic and fourthonce-a-day antiviral approved by the FDA in less than three years.
"We're making great strides in the treatment of HIV infection, butimprovements are still needed," said Joel Gallant, MD, MPH of JohnsHopkins University School of Medicine. "Making therapy easier islikely to improve patients' ability to adhere to therapy. Thisfixed-dose product - a once-a-day treatment as part of combinationtherapy - will make it easier to construct convenient combinationregimens."
Gilead also announced that it has received clearance from the FDAfor an alternate trade dress for Truvada for use in the developingworld. The company plans to include Truvada in the Gilead AccessProgram, an initiative to increase access to anti-HIV medications inthe developing world through sale of the company's antiretrovirals atno-profit pricing. Since 2003, the program has offered Viread at ano-profit price in 68 countries - all countries in Africa and 15 otherUnited Nations-designated "least developed" countries - that represent70 percent of the global AIDS epidemic. Truvada will be available inthe United States as a dark blue capsule-shaped tablet and as asimilarly shaped light blue tablet in the developing world. Thecompany also plans to conduct additional stability studies of Truvadain Climatic Zones III and IV, or hot and humid climates.
The parent compound of Viread, tenofovir, was discovered through acollaborative research effort between Dr. Antonin Holy, Institute forOrganic Chemistry and Biochemistry, Academy of Sciences of the CzechRepublic (IOCB) in Prague and Dr. Erik DeClercq, Rega Institute forMedical Research, Katholic University in Leuven, Belgium. Emtriva wasdiscovered by Dr. Raymond F. Schinazi, Dr. Dennis C. Liotta and Dr.Woo-Baeg Choi and licensed to Gilead by Emory University in 1996.Emory University and the inventors of both Viread and Emtriva, thecomponents in Truvada, have agreed to waive their right to a royaltyon sales of Truvada in the 68 Gilead Access Program countries toensure the product can be offered at a no-profit price in parts of theworld where the epidemic has hit the hardest.
Truvada works by blocking reverse transcriptase, an enzyme crucialfor viral replication. By interfering with the replication process,Truvada, when combined with other anti-HIV medication, can help lowerthe amount of HIV, or "viral load" in a patient's body and increasethe number of immune system cells (called T cells or CD4 cells). Bothof these changes are generally associated with improving a patient'shealth and decreasing the likelihood of AIDS-related illnesses.
It is important that patients be aware that HIV medications mustbe taken as part of combination regimens and do not cure HIVinfection, nor do they reduce its transmission.
"Truvada represents an important step forward in our company'songoing commitment to developing therapeutics that advance patientcare around the world," said John C. Martin, PhD, President and CEO ofGilead. "We are pleased by the FDA's rapid review and approval of thisHIV therapeutic and will work quickly to make it available topatients, including in those resource-limited countries where the HIVepidemic has hit the hardest through the Gilead Access Program." Truvada Indication Truvada is indicated in combination with other antiretroviralagents (such as non-nucleoside reverse transcriptase inhibitors orprotease inhibitors) for the treatment of HIV-1 infection in adults.Safety and efficacy studies using Truvada tablets or using Emtriva andViread in combination are ongoing.
Both components of Truvada have been studied individually, as partof multi-drug regimens and have been found to be safe and effective.Since Emtriva and lamivudine (3TC) are comparable in their structure,resistance profiles, and efficacy and safety as part of multi-drugregimens, existing data from the use of lamivudine and Viread incombination have been extrapolated to support use of Truvada tabletsfor the treatment of HIV-1 infection in adults. Therefore, intreatment-naive patients, Truvada should be considered as analternative to the combination of Viread and lamivudine for thosepatients who might benefit from a once-daily regimen. Intreatment-experienced patients, the use of Truvada should be guided bylaboratory testing and treatment history.
There are no study results demonstrating the effect of Truvada onclinical progression of HIV-1, and it is not recommended that Truvadabe used as a component of a triple nucleoside regimen. Important Safety Information Lactic acidosis and severe hepatomegaly with steatosis, includingfatal cases, have been reported with the use of nucleoside analoguesalone or in combination with other antiretrovirals. Truvada is notindicated for the treatment of chronic hepatitis B virus (HBV)infection and the safety and efficacy of Truvada have not beenestablished in patients co-infected with HBV and HIV. Severe acuteexacerbations of hepatitis B have been reported in patients who havediscontinued Emtriva or Viread. Hepatic function should be monitoredclosely with both clinical and laboratory follow-up for at leastseveral months in patients who discontinue Truvada and are co-infectedwith HIV and HBV. If appropriate, initiation of anti-hepatitis Btherapy may be warranted.
No drug interaction studies have been conducted using Truvada.Drug interactions have been observed when didanosine, atazanavir, orlopinavir/ritonavir is co-administered with Viread, a component ofTruvada. Detailed prescribing information contains additionalinformation on drug interactions, including dose adjustment guidelinesfor co-administration of Truvada with didanosine or atazanavir.Truvada should not be used with Viread or Emtriva, or other drugscontaining lamivudine, including Combivir(R), Epivir(R), Epivir-HBV(R)or Trizivir(R).
Changes in body fat have been observed in patients taking Viread,Emtriva and other anti-HIV medicines. The cause and long term healtheffect of these conditions are unknown.
Two-hundred eighty-three patients have received combinationtherapy with Emtriva and Viread with either a non-nucleoside reversetranscriptase inhibitor or protease inhibitor for 24 to 48 weeks inongoing clinical studies. Based on these limited data, no new patternsof adverse events were identified and there was no increased frequencyof established toxicities.
Adverse events that occurred in more than 5 percent of patientsreceiving Emtriva with other antiretroviral agents in clinical trialsinclude abdominal pain, asthenia (weakness), headache, diarrhea,nausea, vomiting, dizziness, and rash. Approximately 1 percent ofpatients discontinued participation because of these events. Alladverse events were reported with similar frequency in Emtriva andcontrol treatment groups with the exception of skin discolorationwhich was reported with higher frequency in the Emtriva treated group.Skin discoloration, manifested by hyperpigmentation on the palmsand/or soles was generally mild and asymptomatic. The mechanism andclinical significance are unknown.
Adverse events that occurred in more than 5 percent of patientsreceiving Viread with other antiretroviral agents in clinical trialsinclude headache, nausea, diarrhea, vomiting, rash and depression.Less than 1 percent of patients discontinued participation because ofgastrointestinal events. Renal impairment, including serious cases,has been reported. Renal impairment occurred most often in patientswith underlying systemic or renal disease or in patients takingconcomitant nephrotoxic agents, though some cases have appeared inpatients without identified risk factors. Decreases in bone mineraldensity (BMD) at the lumbar spine and hip have been seen with the useof Viread. The clinical significance of changes in BMD and biochemicalmarkers is unknown and follow-up is continuing to assess long-termimpact. About Gilead Sciences Gilead Sciences is a biopharmaceutical company that discovers,develops and commercializes therapeutics to advance the care ofpatients suffering from life-threatening diseases worldwide. Thecompany has seven marketed products, and focuses its research andclinical programs on anti-infectives. Headquartered in Foster City,CA, Gilead has operations in North America, Europe and Australia.
This press release includes forward-looking statements, within themeaning of the Private Securities Litigation Reform Act of 1995, thatare subject to risks, uncertainties and other factors, including therisk that the safety and efficacy data obtained in controlled clinicaltrials for Viread and Emtriva will not be observed in an uncontrolledclinical setting, and the risk that physicians and regulatory agenciesmay not see advantages of Truvada over other antiretrovirals and maytherefore be reluctant to prescribe or grant regulatory approval forTruvada. These risks and uncertainties could cause actual results todiffer materially from those referred to in the forward-lookingstatements. Risks are described in detail in the Gilead Annual Reporton Form 10-K for the year ended December 31, 2003 and in Gilead'sQuarterly Reports on Form 10-Q, all of which are on file with the U.S.Securities and Exchange Commission. All forward-looking statements arebased on information currently available to Gilead and Gilead assumesno obligation to update any such forward-looking statements.
For full prescribing information, please visit www.Truvada.com. Truvada is a trademark and Emtriva and Viread are registeredtrademarks of Gilead Sciences, Inc.
For more information on Gilead Sciences, please visit thecompany's website at www.gilead.com or call Gilead Public Affairs at1-800-GILEAD-5 or 1-650-574-3000. CONTACT: Gilead Sciences, Inc.
Susan Hubbard, 650-522-5715 (Investors)
James Loduca, 650-522-5908 (Media)
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SOURCE: Gilead Sciences, Inc.