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

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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.
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APPENDIX F

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


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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

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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.
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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

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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.
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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

Page 247 Cite Bookmark
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.
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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

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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.
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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.
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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

Page 244 Cite Bookmark
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.
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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.
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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.
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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.
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Page 248 Cite Bookmark
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.
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Page 249 Cite Bookmark
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.
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