National Academies Press: OpenBook

Ending Neglect: The Elimination of Tuberculosis in the United States (2000)

Chapter: Appendix F Approval Dates for Existing and Prospects for Development of New Antituberculosis Drugs and Vaccines

« Previous: Appendix E Estimating the Number of Tuberculosis Cases That Can Be Prevented by a Program of Screening and Preventive Therapy of Newly Arrived Immigrants to the United States from Countries with a High Rate of Tuberculosis a
Suggested Citation:"Appendix F Approval Dates for Existing and Prospects for Development of New Antituberculosis Drugs and Vaccines." Institute of Medicine. 2000. Ending Neglect: The Elimination of Tuberculosis in the United States. Washington, DC: The National Academies Press. doi: 10.17226/9837.
×

Page 244

APPENDIX F

Approval Dates for Existing and Prospects for Development of New Antituberculosis Drugs and Vaccines


Please refer to the page image for an unflawed representation of this content.

TABLE F-1 Approval Dates for Antituberculosis Drugs and Vaccines

Drug

FDA Approval Date or Year of First USPHS Published Trial (*)

Isoniazid

1953*

Rifamycins

rifampin

1974*

rifabutin

12/23/1992

rifapentine

6/22/1998

Pyrazinamide

1959*

Ethambutol

1968*

Streptomycin

1947*

Para-aminosalicylic acid (PAS)

1950*

Ethionamide

1968*

Cycloserine

1968*

Capreomycin

1956*

Kanamycin

Discovered early 1950s; not studied in USPHS trial

Thiacetazone (not available in United States)

Fluoroquinolones

ciprofloxacin

12/26/1990

ofloxacin

12/28/1990

levofloxacin

12/20/1996

Amikacin

Before 1/01/1982

Suggested Citation:"Appendix F Approval Dates for Existing and Prospects for Development of New Antituberculosis Drugs and Vaccines." Institute of Medicine. 2000. Ending Neglect: The Elimination of Tuberculosis in the United States. Washington, DC: The National Academies Press. doi: 10.17226/9837.
×

Page 245


Please refer to the page image for an unflawed representation of this content.

TABLE F-2 Pharmaceutical Companies: Current (1999) Prospects for Development of New Antituberculosis Drugs and Vaccines

New Antimicrobials Available in:

Company

2 Years

5 Years

8 Years

Vaccines

Abbott Laboratories

0

0

0

0

American Home Products (Lederle/Wyeth-Ayerst)

0

0

0

0

Astro-Zeneca Pharmaceuticals

0

0

0

0

Bristol-Myers Squibb

0

0

0

0

Dupont Pharmaceuticals

0

?oxazolidinones

?oxazolidinones

0

Eli Lilly and Company

0

0

0

0

Glaxo-Wellcome

0

0

?

Working on vaccines

  • DNA

  • Whole attenuated live organism

  • Therapeutic vaccine

Hoechst Marion Roussel

0

0

0

0

Rifapentine approved by FDA in 1998

Janssen Pharmaceuticals

0 0

0 0

Merck and Company

0 0

0

Very exploratory; have rights to a DNA vaccine in the public domain. Would also be interested in a subunit vaccine

Suggested Citation:"Appendix F Approval Dates for Existing and Prospects for Development of New Antituberculosis Drugs and Vaccines." Institute of Medicine. 2000. Ending Neglect: The Elimination of Tuberculosis in the United States. Washington, DC: The National Academies Press. doi: 10.17226/9837.
×

Page 246

Novartis Pharmaceuticals

0

0

0

0

Ortho-McNeil Johnson & Johnson

0

Sending some candidate drugs out for in vitro testing; marketing experts not enthusiastic

0

Parke-Davis

0

0

0

0

Pfizer, Inc.

0

0

0

0

Pharmacia/Upjohn

0

?oxazolidinones

?oxazolidinones

0

Rhone-Poulene Rorer

0 0

0 0

Roche Pharmaceuticals

Had some preliminary work on IL-12 but gave up when in animals it increased CFU in lung

Had some preliminary work on IL-12 but gave up when in animals it increased CFU in lung

Had some preliminary work on IL-12 but gave up when in animals it increased CFU in lung

Had some preliminary work on IL-12 but gave up when in up when in animals it increased CFU in lung

Schering-Plough Corp.

0

0

0

0

G.D. Searle-Monsanto Co.

0

0

0

0

Smith Kline Beecham Pharmaceuticals

0

0

0

0

Warners Chilcott Laboratories

0

0

0

0

Warner Lambert Co.

0

0

0

0

Suggested Citation:"Appendix F Approval Dates for Existing and Prospects for Development of New Antituberculosis Drugs and Vaccines." Institute of Medicine. 2000. Ending Neglect: The Elimination of Tuberculosis in the United States. Washington, DC: The National Academies Press. doi: 10.17226/9837.
×

Page 247


Please refer to the page image for an unflawed representation of this content.

TABLE F-3 Biotechnology Companies: Current (1999) Prospects for Development of New Antituberculosis Drugs and Vaccines

New Antimicrobials Available in:

Company

2 Years

5 Years

8 Years

Vaccines

Biogen

0

0

0

0

Corixa Corp.

0

0

0

Vaccines are their approach, not antimicrobials

  • Collaborating with Smith Kline Beecham

  • Working on vaccine for 3 years

  • Have developed a vaccine utilizing 3–5 protein antigens made by incorporating genes for these proteins (a synthetic gene) with effective epitopes (multiple) in one recombinant protein

  • Efficacy already shown in a rodent model

  • Safety already shown in monkeys

  • Clinical trials (Brazil and in another country) phase I/II in approximately 1 year

Genetech

0

0

0

0

Genetics Institute

  • IL-12 plus 3 drugs—study vs. TB in Gambia (currently under way)

  • IL-12 plus 3 drugs—study vs. MA-I in patients with genetic defects in interferon receptor

  • IL-12 plus 3 drugs—study in treatment of M. tuberculosis or MA-I in HIV-infected patients, an ACTG study

?

?

?

Pathogenesis Corp.

  • Rifamycin analog (Rifalizyl) with longer half-life cross- resistant with rifampin so not pursuing any longer

  • PA 824 (a nitroimidizopyrene) under development—active as a drug vs. drug-resistant M. tuberculosis (acts by inhibiting glycolipid cell wall synthesis, but at a different step than is inhibited by ethambutol). Presented as a prodrug that is activated in host (as in the case of INH).

0

0

0

Suggested Citation:"Appendix F Approval Dates for Existing and Prospects for Development of New Antituberculosis Drugs and Vaccines." Institute of Medicine. 2000. Ending Neglect: The Elimination of Tuberculosis in the United States. Washington, DC: The National Academies Press. doi: 10.17226/9837.
×

There was a problem loading page 248.

Suggested Citation:"Appendix F Approval Dates for Existing and Prospects for Development of New Antituberculosis Drugs and Vaccines." Institute of Medicine. 2000. Ending Neglect: The Elimination of Tuberculosis in the United States. Washington, DC: The National Academies Press. doi: 10.17226/9837.
×

Page 249

1) Activity: mole for mole as active as INH

2) Orally active

3) Bactericidal

4) Active vs. nongrowing organisms (e.g., M. tuberculosis cultured under anaerobic conditions)

5) Now in initial stages of testing

Ribozyme Pharmaceuticals

0

0

0

0

Sequella Corp.

  • Ethambutol analogs (3 candidates)

Clinical testing probably

Clinical testing probably

Vaccine: Has license for new experimental vaccine (Nature 400[6741]:269; 1999)

  • Shikemic acid pathway

0

0

(inhibitor)

  • New diagnostic being studied: A patch test that may be positive in patients with active disease but not in individuals with prior infection

Suggested Citation:"Appendix F Approval Dates for Existing and Prospects for Development of New Antituberculosis Drugs and Vaccines." Institute of Medicine. 2000. Ending Neglect: The Elimination of Tuberculosis in the United States. Washington, DC: The National Academies Press. doi: 10.17226/9837.
×
Page 244
Suggested Citation:"Appendix F Approval Dates for Existing and Prospects for Development of New Antituberculosis Drugs and Vaccines." Institute of Medicine. 2000. Ending Neglect: The Elimination of Tuberculosis in the United States. Washington, DC: The National Academies Press. doi: 10.17226/9837.
×
Page 245
Suggested Citation:"Appendix F Approval Dates for Existing and Prospects for Development of New Antituberculosis Drugs and Vaccines." Institute of Medicine. 2000. Ending Neglect: The Elimination of Tuberculosis in the United States. Washington, DC: The National Academies Press. doi: 10.17226/9837.
×
Page 246
Suggested Citation:"Appendix F Approval Dates for Existing and Prospects for Development of New Antituberculosis Drugs and Vaccines." Institute of Medicine. 2000. Ending Neglect: The Elimination of Tuberculosis in the United States. Washington, DC: The National Academies Press. doi: 10.17226/9837.
×
Page 247
Suggested Citation:"Appendix F Approval Dates for Existing and Prospects for Development of New Antituberculosis Drugs and Vaccines." Institute of Medicine. 2000. Ending Neglect: The Elimination of Tuberculosis in the United States. Washington, DC: The National Academies Press. doi: 10.17226/9837.
×
Page 248
Suggested Citation:"Appendix F Approval Dates for Existing and Prospects for Development of New Antituberculosis Drugs and Vaccines." Institute of Medicine. 2000. Ending Neglect: The Elimination of Tuberculosis in the United States. Washington, DC: The National Academies Press. doi: 10.17226/9837.
×
Page 249
Next: Appendix G Committee Biographies »
Ending Neglect: The Elimination of Tuberculosis in the United States Get This Book
×
Buy Hardback | $49.95 Buy Ebook | $39.99
MyNAP members save 10% online.
Login or Register to save!
Download Free PDF

Tuberculosis emerged as an epidemic in the 1600s, began to decline as sanitation improved in the 19th century, and retreated further when effective therapy was developed in the 1950s. TB was virtually forgotten until a recent resurgence in the U.S. and around the world-ominously, in forms resistant to commonly used medicines.

What must the nation do to eliminate TB? The distinguished committee from the Institute of Medicine offers recommendations in the key areas of epidemiology and prevention, diagnosis and treatment, funding and organization of public initiatives, and the U.S. role worldwide. The panel also focuses on how to mobilize policy makers and the public to effective action.

The book provides important background on the pathology of tuberculosis, its history and status in the U.S., and the public and private response.

The committee explains how the U.S. can act with both self-interest and humanitarianism in addressing the worldwide incidence of TB.

  1. ×

    Welcome to OpenBook!

    You're looking at OpenBook, NAP.edu's online reading room since 1999. Based on feedback from you, our users, we've made some improvements that make it easier than ever to read thousands of publications on our website.

    Do you want to take a quick tour of the OpenBook's features?

    No Thanks Take a Tour »
  2. ×

    Show this book's table of contents, where you can jump to any chapter by name.

    « Back Next »
  3. ×

    ...or use these buttons to go back to the previous chapter or skip to the next one.

    « Back Next »
  4. ×

    Jump up to the previous page or down to the next one. Also, you can type in a page number and press Enter to go directly to that page in the book.

    « Back Next »
  5. ×

    Switch between the Original Pages, where you can read the report as it appeared in print, and Text Pages for the web version, where you can highlight and search the text.

    « Back Next »
  6. ×

    To search the entire text of this book, type in your search term here and press Enter.

    « Back Next »
  7. ×

    Share a link to this book page on your preferred social network or via email.

    « Back Next »
  8. ×

    View our suggested citation for this chapter.

    « Back Next »
  9. ×

    Ready to take your reading offline? Click here to buy this book in print or download it as a free PDF, if available.

    « Back Next »
Stay Connected!