1 / 10

BiDil ® (isosorbide dinitrate/ hydralazine HCl)

BiDil ® (isosorbide dinitrate/ hydralazine HCl). Cardiovascular and Renal Drugs Advisory Committee Gaithersburg, Maryland June 16, 2005. Introduction. Manuel Worcel, MD NitroMed. Isosorbide dinitrate (ISDN) Large and small artery dilator Venous dilator Nitric oxide donor

ramla
Download Presentation

BiDil ® (isosorbide dinitrate/ hydralazine HCl)

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. BiDil® (isosorbide dinitrate/ hydralazine HCl) Cardiovascular and Renal Drugs Advisory Committee Gaithersburg, Maryland June 16, 2005

  2. Introduction Manuel Worcel, MDNitroMed

  3. Isosorbide dinitrate (ISDN) Large and small artery dilator Venous dilator Nitric oxide donor Hydralazine HCl (HYD) Arteriolar dilator BiDil Fixed-dose combination ISDN/HYD (20 mg and 37.5 mg, respectively, per tablet) BiDil® Mechanism of Action DV A-HeFT CSR p28;Underwood_ACC-5 O2NO H O O H ONO2 1, 4, 3, 6-dianhydro-D-glucitol-2,5-dinitrate; C6H8N2O8 NHNH2 N HCl N 1-hydrazinophthalazine monohydrochloride; C8H9ClN4

  4. BiDil® Clinical Development in HF† DV NitroMed Briefing Book T1; V-HeFT I CSR; V-HeFT II CSR 1980 to 1985 V-HeFT I Vasodilator-Heart Failure Trial 642 men 1986 to 1991 V-HeFT II Vasodilator-Heart Failure Trial 804 men 2001 to 2004 A-HeFT African American Heart Failure Trial 1050 black men and women † V-HeFT trials used ISDN + HYD as commercial products.

  5. 1997 Medco Research receives FDA “not approvable” letter for use of BiDil to treat HF in the general population 1999 NitroMed acquires NDA file for BiDil 2001 FDA informs NitroMed that an additional clearly positive study in black patients (A-HeFT) would be basis for approval of BiDil in black patients 2004 A-HeFT trial stopped following DSMB and Steering Committee recommendations and NDA amendment submitted in December BiDil® Regulatory History DV NitroMed Briefing Book § 2.5

  6. BiDil® Clinical Development in Black Patients With HF DV NitroMed Briefing Book pp 110, 111 • BiDil is effective: • Meaningfully reduced relative risk of mortality • Meaningfully reduced relative risk of HF hospitalization • Meaningfully improved QoL • BiDil is safe and generally well tolerated • Findings are concordant across a wide range of • Symptoms • Background medications

  7. Proposed Indication BiDil® is indicated for the treatment of heart failure as an adjunct to standard therapy in black patients to improve survival, prolong time to hospitalization for heart failure, and improve quality of life.

  8. Agenda

  9. Sponsor Representatives

  10. Consultants

More Related