Understanding the regulatory hurdles for antibacterial drug development in the post-Ketek world

Annals of the New York Academy of Sciences

Volumn 1241, Issue 1, 2011, Pages 153-161

  Echols, Roger M ^a  

^a Infectious Disease Drug Development Consulting LLC   (United States)

Author keywords

Antibacterial; Drug development; FDA guidelines; Ketek

Indexed keywords

ANTIINFECTIVE AGENT; CEFTAROLINE; CEFTAROLINE FOSAMIL; CEFTOBIPROLE; CETHROMYCIN; CIPROFLOXACIN; DALBAVANCIN; DORIPENEM; FROPENEM; GARENOXACIN; GEMIFLOXACIN; ICLAPRIM; ORITAVANCIN; TELAVANCIN;

ACUTE DISEASE; ACUTE OTITIS MEDIA; ADVISORY COMMITTEE; ARTICLE; BACTERIAL INFECTION; BACTERIAL SINUSITIS; BACTERIAL SKIN DISEASE; BLURRED VISION; CELLULITIS; CHRONIC BRONCHITIS; COMMUNITY ACQUIRED PNEUMONIA; FOOD AND DRUG ADMINISTRATION; HOSPITAL INFECTION; HUMAN; IN VITRO STUDY; INFECTION; LIVER INJURY; PHASE 3 CLINICAL TRIAL (TOPIC); PNEUMONIA; RANDOMIZED CONTROLLED TRIAL (TOPIC); STREPTOCOCCUS PNEUMONIA; SYSTEMIC THERAPY;

EID: 84255195549     PISSN: 00778923     EISSN: 17496632     Source Type: Book Series    
DOI: 10.1111/j.1749-6632.2011.06300.x     Document Type: Article

References (56)

1. Summary Minutes of the joint meeting of the Anti-Infective Drugs Advisory committee and the Drug Safety and Risk Management Advisory Committee, December 14 and 15, 2006., Accessed Nov. 11, 2011.
2. Edelberg, H.K. 2006. Overview of FDA approval activities for telithromycin. Anti-infectives Drugs Advisory Committee December 14-15., Accessed Nov. 11, 2011.
3. Shlaes, D. & R. Moellering 2008. Telithromycin and the FDA: implications for the future. The Lancet 8: 3-5., Accessed Nov. 11, 2011.
4. Guidance for Industry, Acute Bacterial Sinusitis: Developing Drugs for Treatment. U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER) October 2007 Revision 1., Accessed Nov. 11, 2011.
5. Guidance for Industry, Acute Bacterial Exacerbations of Chronic Bronchitis in Patients with Chronic Obstructive Pulmonary Disease: Developing Antimicrobial Drugs for Treatment. U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER) August 2008 Revision 1., Accessed Nov. 11, 2011.
6. Usdin, S. 2006. FDA's superior attitude. BioCentury 14(41) September 18, A7-A10.
7. Drug Approval Package, April 2002; Study 344, FDA Clinical Review, part 1, p 41-50, Accessed Nov. 11, 2011.
8. Guidance for Industry, Antibacterial Drug Products: Use of Noninferiority Studies to Support Approval. U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER) October 2007., Accessed Nov. 11, 2011.
9. Brenner, R., E.J. Ellis-Grosse & R.M. Echols 2006. Moving goalposts-regulatory oversight of antibacterial drugs. Nat. Biotechnol. 24: 1515-1520.
10. Talbot, G.H., J.S. Bradley, J.E. Edwards, et al 2006. Bad bugs need drugs: an update on the development pipeline from the Antimicrobial Availability Task Force of the Infectious Diseases Society of America. Clin. Infect. Dis. 42: 657-668.
11. Boucher, H.W., G.H. Talbot, J.S. Bradley, et al 2009. Bad bugs, no drugs: no ESKAPE! An update from the Infectious Diseases Society of America. Clin. Infect. Dis. 48: 1-12.
12. Telavancin for the Treatment of Complicated Skin and Skin Structure Infections. FDA Briefing Document for Anti-Infective Drugs Advisory Committee Meeting November 19, 2008., Accessed Nov. 11, 2011.
13. Hass, M.J. & S. Usdin 2007. Antibiotic jigsaw. BioCentury 15: A1-A7
14. Schering-Plough pulls its garenoxacin app. FierceBiotechAugust 20, 2006., Accessed Nov. 11, 2011.
15. FDA rejects new Johnson & Johnson antibiotic. 2009 Star Ledger Wire Services, December 31., Accessed Nov. 11, 2011.
16. Pfizer pulls Dalbavancin applications to conduct more trials. 2008. FDA News 6: September 17., Accessed Nov. 11, 2011.
17. Iclaprim for the Treatment of Complicated Skin and Skin Structure Infections, FDA Briefing Document for Anti-Infective Drugs Advisory Committee Meeting November 20, 2008., Accessed Nov. 11, 2011.
18. Summary Minutes of the Anti-Infective Drugs Advisory Committee November 18-20, 2008 (oritavancin)., Accessed Nov. 11, 2011.
19. Haas, M.J. 2009. The old rules are capped. BioCentury 17(25): June 8, A19-A21.
20. Smith, T. 2008. Clinical efficacy of doripenem in nosocomial pneumonia. Anti-infectives Drugs Advisory Committee presentation. July 16., Accessed Nov. 11, 2011.
21. Singer M., S. Nambiar, T. Valappil, et al 2008. Historical and regulatory perspectives on the treatment effect of antibacterial drugs for community-acquired pneumonia. Clin. Infect. Dis. 47: S216-S224.
22. Spellberg, B., G.H. Talbot, H.W. Boucher, et al 2009. Antimicrobial agents for complicated skin and skin-structure infections: justification of non-inferiority margins in the absence of placebo-controlled trials. Clin. Infect. Dis. 49: 383-391.
23. Higgins, K. 2010. Introduction to the non-inferiority trial design. In Issues in the Design and Conduct of Clinical Trials for Antibacterial Drug Development. A public workshop sponsored by the FDA. August 2, day 1, session 1. (pp. 53-72), Accessed Nov. 11, 2011.
24. ICH harmonization tripartite guideline choice of control group and related issues in clinical trials E10 20 July 2000. P.10-11., Accessed Nov. 11, 2011.
25. Guidance for Industry, Community-Acquired Bacterial Pneumonia: Developing Drugs for Treatment. U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) March 2009 Revision 1., Accessed Nov. 11, 2011.
26. Guidance for Industry, Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia: Developing Drugs for Treatment. U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER), November 2010 Clinical/Antimicrobial Revision 1., Accessed Nov. 11, 2011.
27. Echols, R.M., G.S. Tillotson, J.X. Song & R.L. Tosiello 2008. Clinical trial design for mild-to-moderate community-acquired pneumonia-an industry perspective. Clin. Infect. Dis. 47: S166-S175
28. FDA Briefing Document. Ceftaroline Anti-infectives Drugs Advisory Committee (AIDAC), September 7, 2010., Accessed Nov. 13, 2011.
29. Guidance for Industry. Acute Bacterial Skin and Skin Structure Infections: Developing Drugs for Treatment. U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER) August 2010 Revision 127., Accessed Nov. 13, 2011.
30. Nambiar, S. 2010. Primary efficacy endpoints in antibacterial drug trials: FDA perspective. In Issues in the Design and Conduct of Clinical Trials for Antibacterial Drug Development. A Public Workshop Sponsored by the FDA. August 2, day 1, session 2. Transcript p. 214-215, Accessed Nov. 13, 2011.
31. Developing Endpoints for Clinical Trials of Drugs for Treatment of Acute Bacterial Skin and Skin Structure Infections and Community-Acquired Bacterial Pneumonia. Foundation for the National Institutes of Health Working Group Meeting. Meeting minutes, May 5, 2010., Accessed Nov. 13, 2011.
32. Critical Path Opportunities Report and List. U.S. Department of Health and Human Services, Food and Drug Administration, March 2006., Accessed Nov. 13, 2011.
33. Guidance for Industry, Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims. U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER) Center for Devices and Radiological Health (CDRH) December 2009., Accessed Nov. 13, 2011.
34. Prospective, Multicenter, Randomized, Double-Blind, Placebo Controlled Trial to Evaluate the Efficacy and Safety of Moxifloxacin 400 mg QD for 5 Days Versus Placebo in the Treatment of Acute Bacterial Sinusitis. ClinicalTrials.gov identified: NCT00492024.
35. Echols, R., R. Tosiello, M. Garfield, et al.2008 Superiority of an antibiotic (faropenem medoxomil) versus placebo for the treatment of AECB. 48th ICCAC and 46th IDSA Annual Meeting. Washington, DC October 2008. Poster L-662a.
36. Ceftaroline Product Label. March 11, 2011 Drugs@FDA, Accessed Nov. 13, 2011.
37. Young, D. 2010. ALS pursues first-of-its-kind antibiotic superiority trial. BioWorld Today 21:, Accessed Nov. 13, 2011.
38. Justification of non-inferiority margin for complicated intra-abdominal infections. FDA Medical Review, NDA-022106 (doripenem), part 1, 2007, appendix 1, 18-27., Accessed Nov. 13, 2011.
39. Ross, D. 2007. The FDA and the case of Ketek. N. Engl. J. Med. 356: 1601-1604.
40. Soreth, J., E. Cox, S. Kweder, J. Jenkins & S. Galson 2007. Ketek-the FDA perspective. N. Engl. J. Med. 356: 1675-1676.
41. Food and Drug Administration Amendment Act of 2007. Referral to advisory committee, section 918., Accessed Nov. 13, 2011.
42. Ball, LK. 2010. Overview of good clinical practice: DSI perspective. In Issues in the Design and Conduct of Clinical Trials for Antibacterial Drug Development, August 2-3. Day 2, sessions 3 & 4 part 1.
43. Herper, M. 2009. The FDA's infection. March 2., Accessed Nov. 13, 2011.
44. FDA issues ceftobiprole complete response letter. Marketwire 2009., Accessed Nov. 11, 2011.
45. Johnson & Johnson Pharmaceutical Research & Development, LLC. Warning letter. 8/10/09C:\Users\Owner\Documents\Politics of Antibiotic Development\Warning letter ceftobiprol Aug 09.mht Reuters.com August 18, 2009, Accessed Nov. 13, 2011.
46. Basilea Pharmaceutica files claims against Johnson & Johnson over its handling of ceftobiprole (ZEFTERA™/Zevtera™) clinical studies. Basilea Pharmaceutica AG. February 24, 2009., Accessed Nov. 13, 2011.
47. Shlaes, D.M. 2010. Antibiotics: The Perfect Storm. Springer, New York, NY
48. Fleming, T.R. & J.H. Powers 2008 Issues in non-inferiority trials: the evidence in community-acquired pneumonia. Clin. Infect. Dis. 47: S108-S120.
49. Sorbello, F., S. Komo & T. Valappil 2010. Noninferiority margin for clinical trials of antibacterial drugs for nosocomial pneumonia. Drug Inform. J. 44: 165-176.
50. Guidance for Industry, Acute Bacterial Otitis Media: Developing Drugs for Treatment. U.S. Department of Health and Human Services Food and Drug Administration, Center for Drug Evaluation and Research (CDER), January 2008, Clinical Antimicrobial Revision 1.
51. ® (gemifloxacin mesylate) Tablets For the Treatment of Acute Bacterial Sinusitis Briefing Document. NDA #21-158 S-006, August 7, 2006, Accessed Nov. 13, 2011.
52. Minutes of FDA Anti-infective Drugs Advisory Committee, September 12, 2006; pp. 294-303, Accessed Nov. 13, 2011.
53. Theravance Announces Receipt of Additional FDA Communication Regarding Telavancin NDA for the Treatment of Nosocomial Pneumonia, Accessed Nov. 13, 2011.
54. Fine, M., E. Auble, D.M. Yealy, et al. 1997. A prediction rule to identify low-risk patients with community acquired pneumonia. N. Engl. J. Med. 336: 243-250.
55. Shlaes D, RC Moellering 2002 The United States food and drug administration and the end of antibiotics Clin. Infect. Dis. 34: 420-422.
56. FDA Issues Ceftobiprole Complete Response Letter, Fierce BioTech, December 31, 2009. December 30, 2009, Accessed Nov. 13, 2011.