|
|
Application of animal rule in the development of drugs and biological products for the prevention and control of infectious diseases |
GAO Ming, JIAO Lei, WANG Bing-xiang |
No. 3 Research Laboratory, Lan Zhou Institute of Biological Products Co., Ltd.,Center for Gansu Provincial Vaccine Engineering Research, Lanzhou 730046, China |
|
|
Abstract This article describes the background and content of the "animal rule", and the relevant requirements of the FDA for the approval of disease prevention drugs and biological products that cannot be used for clinical experiments in the human body, such as anthrax, based on the "animal rule". In this paper, some products approved by FDA according to "animal rule" in recent years are briefly introduced, including product characteristics, experimental results of animal effectiveness and matters needing attention in use. The summary shows that "animal rule" puts forward strict requirements for product developers, at the same time, it is suggested that developers should keep close communication with FDA in a series of processes before and after development, and design and develop products to solve practical problems.
|
Received: 09 April 2018
|
|
Fund:Supported by the National Science and Technology Major Projects for "Major New Drugs innovation and Development"(No.20142X09102047) |
Corresponding Authors:
Wang Bing-xiang,Email:wangbxa@126.com
|
|
|
|
[1] Food and Drug Administration, HHS. New drug and biological drug products; evidence needed to demonstrate effectiveness of new drugs when human efficacy studies are not ethical or feasible. Final rule[J]. Fed Regist,2002, 67(105):37988-37998. PMID: 12049094. [2] 董树林,王秉翔.炭疽[M]. 西安: 陕西科学技术出版社, 2004:1-10. [3] Dos Santos Grácio AJ, Grácio MAA. Plague in Madagascar[J]. Trop Doct, 2018, 48(1):1-2. DOI: 10.1177/0049475517749302. [4] Chudzicka A. Intoxication of botulinum toxin[J]. Pol Merkur Lekarski, 2015, 39(231):153-156. PMID: 26449577. [5] Rossi CA, Ulrich M, Norris S, et al.Identification of a surrogate marker for infection in the African green monkey model of inhalation anthrax[J]. Infect Immun, 2008, 76(12):5790-5801. DOI: 10.1128/iai.00520-08. [6] Henning LN, Comer JE, Stark GV, et al.Development of an inhalational Bacillus anthracis exposure therapeutic model in cynomolgus macaques[J]. Clin Vaccine Immunol, 2012, 19(11): 1765-1775. DOI: 10.1128/cvi.00288-12. [7] Ionin B, Hopkins RJ, Pleune B, et al.Evaluation of immunogenicity and efficacy of anthrax vaccine adsorbed for postexposure prophylaxis[J]. Clin Vaccine Immunol, 2013, 20(7): 1016-1026. DOI: 10.1128/cvi.00099-13. [8] Fellows P, Lin W, Detrisac C, et al.Establishment of a Swiss Webster mouse model of pneumonic plague to meet essential data elements under the animal rule[J]. Clin Vaccine Immunol, 2012, 19(4):468-476. DOI: 10.1128/cvi.05591-11. [9] Bergman KL, Krudys K, Seo SK, et al.Modeling and simulation in dose determination for biodefense products approved under the FDA animal rule[J]. J Pharmacokinet Pharmacodyn, 2017, 44(2):153-160. DOI: 10.1007/s10928-017-9516-2. [10] Longstreth J, Skiadopoulos MH, Hopkins RJ.Licensure strategy for pre-and post-exposure prophylaxis of biothrax vaccine: the first vaccine licensed using the FDA animal rule[J]. Expert Rev Vaccines, 2016, 15(12):1467-1479. DOI: 10.1080/14760584.2016.1254556. [11] Zeng M, Xu Q, Pichichero ME.Protection against anthrax by needle-free mucosal immunization with human anthrax vaccine[J]. Vaccine, 2007, 25(18):3588-3594. DOI: 10.1016/j.vaccine.2007.01.075. [12] Beasley DWC, Brasel TL, Comer JE.First vaccine approval under the FDA Animal Rule[J]. NPJ Vaccines, 2016, 1:16013. DOI: 10.1038/npjvaccines.2016.13 [13] Savransky V, Shearer JD, Gainey MR, et al.Correlation between anthrax lethal toxinneutralizing antibody levels and survival in guinea pigs and nonhuman primates vaccinatedwith the AV7909 anthrax vaccine candidate[J]. Vaccine, 2017, 35(37):4952-4959. DOI:10.1016/j.vaccine.2017.07.076 [14] Singh H, Ratol S, Thangaraju P, et al.Pharmacology and Anti-infective role of raxibac-umab: a Novel monoclonal antibody for the treatment of Anthrax[J]. West Indian Med J, 2016, 65(2):358-362. DOI: 10.7727/wimj.2015.099 [15] Tsai CW, Morris S.Approval of raxibacumab for the treatment of inhalation Anthrax Under the US food and drug administration "animal rule"[J]. Front Microbiol, 2015, 6:1320. DOI: 10.3389/fmicb.2015.01320 [16] Migone TS, Subramanian GM, Zhong J, et al.Raxibacumab for the treatment of inhalational anthrax[J]. N Engl J Med, 2009, 361(2):135-144. DOI: 10.1056/nejmoa0810603 [17] Migone TS, Bolmer S, Zhong J, et al.Added benefit of raxibacumab to antibiotic treatment of inhalational anthrax[J]. Antimicrob Agents Chemother, 2015, 59(2):1145-1151. DOI: 10.1128/aac.04606-14 [18] Subramanian GM, Cronin PW, Poley G, et al.A phase 1 study of PAmAb, a fully human monoclonal antibody against Bacillus anthracis protective antigen, in healthy volunteers[J]. Clin Infect Dis, 2005, 41(1):12-20. DOI: 10.1086/430708 [19] Rubinson L Md PhD, Corey A, Hanfling D. Estimation of time period for effective human inhalational anthrax treatment including antitoxin therapy[J]. PLoS Curr, 2017, 9. DOI: 10.1371/currents.outbreaks.7896c43f69838f17ce1c2c372e79d55d [20] Yu PA, Lin NH, Mahon BE, et al.Safety and Improved Clinical Outcomes in Patients Treated With New Equine-Derived HeptavalentBotulinum Antitoxin[J]. Clin Infect Dis, 2017, 66(suppl_1):S57-S64. DOI: 10.1093/cid/cix816 [21] Schussler E, Sobel J, Hsu J, et al.Workgroup report by the joint task force involving american academy of allergy, asthma & immunology (AAAAI); food allergy, anaphylaxis, dermatology and drug allergy (FADDA) (Adverse Reactions to foods committee and adverse reactions to drugs, biologicals, and latex Committee); and the centers for Disease control and prevention botulism clinical treatment guidelines workgroup-allergic reactions to botulinum antitoxin: a systematic review[J]. Clin Infect Dis, 2017, 66(suppl_1):S65-S72. DOI: 10.1093/cid/cix827 [22] Cui X, Nolen LD, Sun J, et al.Analysis of anthrax immune globulin intravenous with antimicrobial treatment in injection drug users, scotland, 2009-2010[J]. Emerg Infect Dis, 2017, 23(1):56-65. DOI: 10.3201/eid2301.160608 [23] Kammanadiminti S, Patnaikuni RK, Comer J, et al.Combination therapy with antibiotics and anthrax immune globulin intravenous (AIGIV) is potentially more effective than antibiotics alone in rabbit model of inhalational anthrax[J]. PLoS One, 2014, 9(9):e106393. DOI: 10.1371/journal.pone.0106393 [24] Mytle N, Hopkins RJ, Malkevich NV, et al.Evaluation of intravenous anthrax immune globulin for treatment of inhalation anthrax[J]. Antimicrob Agents Chemother, 2013, 57(11): 5684-5692. DOI: 10.1128/aac.00458-13 [25] Chen Z, Moayeri M, Purcell R.Monoclonal antibody therapies against anthrax[J]. Toxins, 2011, 3(8):1004-1019. DOI: 10.3390/toxins3081004 [26] Nagy CF, Leach TS, Hoffman JH, et al.Pharmacokinetics and tolerability of obiltoxaximab: A report of 5 healthy volunteer studies[J]. Clin Ther, 2016, 38(9):2083-2097. DOI: 10.1016/j.clinthera.2016.07.170 [27] Yamamoto BJ, Shadiack AM, Carpenter S, et al.Efficacy projection of obiltoxaximab for treatment of inhalational anthrax across a range of disease severity[J]. Antimicrob Agents Chemother, 2016, 60(10):5787-5795. DOI: 10.1128/aac.00972-16 [28] Pittman PR, Hack D, Mangiafico J, et al.Antibody response to a delayed booster dose of anthrax vaccine and botulinum toxoid[J]. Vaccine, 2002, 20:2107-2115. DOI: 10.1016/s0264-410x(02)00058-0 |
|
|
|