2009年在研的183種糖尿病藥Diabetes_圖文(精)

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14、gies type 2 diabetes Phase I (oralCedar Kn oils, NJ(973 532-8000 GLP-1 FC Eli Lilly type 2 diabetes Phase II Indianapolis, IN(800 545-5979 GLP-1 PEG Eli Lilly type 2 diabetes Phase I Indianapolis, IN(800 545-5979 HDV-i nsulin Diasome Pharmaceuticals type 2 diabetes Phase II Con shohocke n, PA(609 92

15、3-9443 HE3286Hollis-Eden type 2 diabetes Phase II Pharmaceuticals(858 587-9333 San Diego, CA HSD016Wyeth Pharmaceuticals diabetes Phase I Collegeville, PA(800 934-5556 IL-1 an tibody Eli Lilly type 2 diabetes Phase I In dia napolis, IN(800 545-5979 INCB-137391 ncyte type 2 diabetes Phase II Wilmi ng

16、to n, DE(302 498-6700 INCB-19602I ncyte type 2 diabetes Phase II Wilmi ngto n, DE(302 498-6700 INCB-20817I ncyte type 2 diabetes Phase II Wilmi ngto n, DE(302 498-6700 INGAP peptide Kin exum Metabolics type 1 diabetes, type 2 diabetes Phase II insulin inhalation Baxter Healthcare diabetes Phase I De

17、erfield, IL(800 422-9837 in sulin in halati on MicroDose Tech no logies diabetes Phase I completed Monm outh Jun ctio n, NJ(732 355-2100 in sulin nasal spray MDRNA type 2 diabetes Phase II Bothell, WA(425 908-3601 completed Harper s Ferry, WV(3043 in sulin oral Emisphere Tech no logies type 2 diabet

18、es Phase l/ll Cedar Kn oils, NJ(973 532-8000 in suli n oral Gen erex Biotech no logy type 1 diabetes Phase Ill Toro nto, Can ada(416 364-2551 in sulin tran sdermal Dermis onics type 1 diabetes, type 2 diabetes Phase l Irvine, CA(888 401-3376 INT-1311 nteKrin Therapeutics type 2 diabetes Phase ll Los

19、 Altos, CA(650 941-5501 In tesuli n? Coremed diabetes Phase l in sulin oral Lake Bluff, IL(847 772-6868 ISIS 113715lsis Pharmaceuticals type 2 diabetes Phase II Carlsbad, CA(comb in atio n therapy(800 679-4747 ISIS-SGLT2rx Isis Pharmaceuticals type 2 diabetes Phase I Carlsbad, CA(800 679-4747 JTT-65

20、4Akros Pharma type 2 diabetes Phase I Princeton, NJ(609 919-9570 DlARf VES. Tvrr 1 ANO T VFf 2 4M* rvjw i own rw u . : r Ci MM* tlT fjM. Mf twli nn 2 丄 2? W4 X ZZI W w r.w 54sm mu FKiM CZ1ZI 1W.4C11I ft A A r ! M l 72X0 rw i 純”,Z4W 4U 7-U|Bi ft A A II V JKHO MH JMU MIOHI Mmt Mm. 小fi M 嚴(yán)十 4LAW * Dl A

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25、 chronic disease in which the body does not produce or properly use in suli n, a horm one that is n eeded to convert sugar, starches and other food into en ergy needed for daily life. Symptoms may include excessive thirst, hunger, urination and weight loss. The cause of dia-betes con ti nues to be a

26、 mystery, although both gen etics and en vir on-men tal factors such as obesity and lack of exercise appear to play roles. Type 1 diabetes, the more severe form, results from the body s failure to produce insulin, which “ uni ocks ” the cells of the body, allow in gqglue to en ter and fuel them. It

27、is estimated that 5 perce nt to 10 per-ce nt of America ns who are diag-no sed with diabetes have type 1, which requires insulin treatment. Type 2 diabetes results from insulin resistance (a condition in which the body fails to properly use insulin, combined with relative insulin defi-cie ncy. Most

28、America ns who are diag no sed with diabetes have type 2, which in most cases can be con-trolled by a comb in ati on of dietary measures, weight loss, and oral medicati on. diabetic peripheral n europathy- Nerve damage in the arms, han ds, legs, and feet caused by diabetes. The con diti on develops

29、slowly and worse ns over time. Depe nding on the types of n erves invo Ived, one or more sig ns and symptoms may be prese nt in diabetic peripheral neu-ropathy. Sensory neuropathy results in numbness or tingling in the feet or pain or discomfort in the feet or legs, in cludi ng prickly, sharp pain o

30、r bur ning feet. Motor n europathy invo Ives muscle weak ness and loss of muscle tone in the feet and lower legs, loss of bala nce, or cha nges in foot shape that can lead to areas of in creased pressure. Aut ono mic n eu- ropathy results in dry feet and cracked skin. The loss of sen sati on and oth

31、er problems associated with n erve damage make a patie nt prone to develop ing skin ulcers (ope n sores that can become in fected and may not heal. This serious complica- ti on of diabetes can lead to the loss of a foot, a leg, or eve n a life. diabetic ret ino pathy The most com mon diabetic eye di

32、sease and a leadi ng cause of bli ndn ess in American adults. It is caused by cha nges in the blood vessels of the retina, the light-sensitive tissue at the back of the eye that is n ecessary for good visi on. In some people with diabetic reti no pathy, blood vessels may swell and leak fluid. In oth

33、ers, abno rmal new blood vessels grow on the surface of the reti na. Over time, diabetic ret in opathy, which usually affects both eyes, can worse n and cause visi on loss. The con diti on has four stages: 1 mild non proliferative retinopathy, the earliest stage duri ng which microa neurysms occur i

34、n the retina s tiny blood vessels; 2 moderate non proliferative reti no pa- thy, duri ng which some blood vessels that no urish the reti na are blocked; 3 severe non proliferative reti nopathy, whe n many more blood vessels are blocked and deprive several areas of the ret ina with their blood supply

35、; and 4 proliferative reti nopathy, the adva need stage when sig nals sent by the reti na for no urishme nt trigger the growth of new blood vessels, which grow along the ret ina and the surface of the clear, vitreous gel that fills the in side of the eye. If those thi n, fragile blood vessels leak b

36、lood, severe visi on loss and eve n bli ndn ess can result. Up to 45 perce nt of America ns diag no sed with diabetes have some stage of diabetic ret in opathy. macular edema- A con diti on in which fluid can leak into the center of the macula, the part of the eye where sharp, straight-ahead visi on

37、 occurs. The fluid makes the macula swell, thus blurri ng visi on .It can occur at any stage of diabetic retinopathy, although it is more likely to occur as the disease progresses. About half of the people with proliferative reti nopathy also have macular edema. Phase Safety testi ng and pharmacolog

38、ical profili ng of new drugs in small nu mbers of huma ns. Phase I Effective ness testi ng and iden tificati on of side effects of new drugs in huma ns. Phase III Exte nsive cli nical trials in huma ns to verify effective ness and mon itor adverse reacti ons of new drugs. polyn europathy A diffuse p

39、eripheral n erve disorder that is bilaterally symmetrical and thus not confined to the distributi on of a sin gle n erve or a sin gle limb. Electrodiag no stic tests are done to classify the n erve structures invo Ived, their distribu tion, and the severity of the disorder in order to help ide ntify

40、 the cause. Some polyn europathies, such as those caused by lead toxicity or tick bite, affect primarily motor fibers. Others, such as those caused by diabetes or AIDS, affect primarily sen sory fibers. Diabetic n europathies 13 I；尸 ci ATJ An. ia._ rvir Ki irni i A. ifz-br 円旦* 卅了、八 3*阻 和 inc iHa tKc

41、i 也 If thzxiia th can also affect cranial n erves. S H I nt) FA rs ABOUT DI ABI I t S IN V HI UNITID STATES1 1 * te9 i H I* * w tah dfv. 4.1X* |a v * JU? *W CM* 穴 swv i p c0 * jo ct Mkt Il lta C*4#* (臥 *MK 4f MWNI I 倆4 w Wai %円 I eh yn 12-H Ww 尸*1 4 AmMyi f Ml JAnaKm W7 |w m. 3 . 5v iw * 8 d3 ? “ I

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44、VXII 4w i-o*M! #*”)、 * .4“*3 Ml E.d. Oav MH d %wv ltr rw fec vwiMf* uttv 4ly wrf # * m vw i ID JV* kaftM* 柚 JMMM! a .X. 15 T H E DRUG DEVELOPMENT AND APPROVAL PROC he U.S. system ot new drug approvals is perhaps the most rigorous in the world It takes 10-15 years, on average, tor an experimental dru

45、g to travel from lab to U.S. patients, according to the Tutts Center for the Study of Drug Development, based on drugs approved from 1 994 through 1998 Only five in 5,000 compounds that enter preclinical testing make it to human testing. And only onm of those five is approved for sale. On average, i

46、t costs a company $1.3 billion to get one new medicine from the laboratory to U.S. patients, according to a 2007 study by the Tutts Center for the Study of Drug Development. Once a new compound has been identified in the laboratory, medicines are developed as follows: Preclinical Testing. A pharmace

47、utical company corv ducts laboratory and animal studies to show biological * * MM I * * HT I MWWMI rvhM AnVcc T Clinical Trials, Phase I. These tests involve c to 100 normal, healthy volunteers. The tests drugs safety T he U.S. system of new drug approvals is perhaps the most rigorous in the world.

48、It takes 10-15 years, on average, for an experimental drug to travel from lab to U.S. patie nts, accord ing to the Tufts Cen ter for the Study of Drug Developme nt, based on drugs approved from 1994 through 1998. Only five in 5,000 compo unds that en ter preclinical testing make it to human testing.

49、 And only one of those ?veis approved for sale. On average, it costs a company $1.3 billion to get one new medicine from the laboratory to U.S. patie nts, accordi ng to a 2007 study by the Tufts Cen ter for the Study of Drug Developme nt. Once a new compound has been identified in the laboratory, me

50、dicines are developed as follows: Precli nical Testi ng. A pharmaceutical compa ny con -ducts laboratory and animal studies to show biological activity of the compound against the targeted disease, and the compo und is evaluated for safety. Inv estigati onal New Drug Applicati on (IND.After complet

51、ing precli ni cal test ing, a compa ny ?les an IND with the U.S. Food and Drug Admi nistrati on (FDA to beg in to test the drug in people. The IND becomes effective if FDA does not disapprove it within 30 days. The IND shows results of previous experiments; how, where and by whom the new studies wil

52、l be con ducted; the chemical structure of the compo und; how it is thought to work in the body; any toxic effects found in the ani mal studies; and how the compo und is man -ufactured. All clinical trials must be reviewed and approved by the Institutional Review Board (IRB where the trials will be

53、con ducted. Progress reports on cli nical trials must be submitted at least annu ally to FDA and the IRB. Clinical Trials, Phase I.These tests involve about 20 to 100 normal, healthy volunteers. The tests study a drug s safety profile, including the safe dosage range. The studies also determ ine how

54、 a drug is absorbed, distributed, metabolized, and excreted as well as the duration of its action. Cli nical Trials, Phase ll.ln this phase, con trolled trials of approximately 100 to 500 volunteer patients (people with the disease assess a drug s effectiveness. Cli nical Trials, Phase III.This phas

55、e usually in volves 1,000 to 5,000 patie nts in cli nics and hospitals. Physicia ns mon itor patie nts closely to con?rm ef?cacy and ide ntify adverse eve nts. New Drug Applicati on (NDA/Biologic Lice nse Applicatio n (BLA.Followi ng the completi on of all three phases of cli ni cal trials, a compa

56、ny an alyzes all of the data and files an NDA or BLA with FDA if the data successfully dem on strate both safety and effec -tive ness. The applicati ons con tai n all of the scie ntific in formatio n that the compa ny has gathered. Applications typically run 100,000 pages or more. The average review

57、 time for the 24 new therapeutics approved by the FDA in 2008 was 17.8 mon ths. Approval.O nee FDA approves an NDA or BLA, the new medici ne becomes available for physicians to prescribe. A company must continue to submit periodic reports to FDA, in clud ing any cases of adverse reacti ons and appro

58、priate quality-c on trol records. For some medicines, FDA requires additional trials (Phase IV to evaluate longterm effects. Discoveri ng and develop ing safe and effective new medic ines is a long, difficult, and expe nsive process. Pharmaceutical compa nies in vested an estimated $65.2 billi on in

59、 research and developme nt in 2008. Shari ng Miracles Televisi on Program Features In spirati onal Stories of Real Diabetes Patie nts S hari ng Miraclea 30-minute public affairs televisi on program- tells the compelling and inspirational stories of real patients. Two recent episodes focused on patie

60、 nts who suffer from diabete Leave It to Beaver star Jerry Mathers and professi onal basketball star Domi nique Wilki ns. Mathers is an America n icon, best known for his portrayal of the mischievous Theodore “ Beaver ” Cleaver. Currently shown on TV Land and in coun tries throughout the world, Leave It to Bea