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Center for Drug Evaluation and Research CENTER FOR DRUG EVALUATION AND RESEARCH APPROVAL PACKAGE for: APPLICATION NUMBER: 050742 TRADE NAME: Mectizan GENERIC NAME: Ivermectin SPONSOR: Merck Research Laboratories APPROVAL DATE: 11/22/96 ~.*SI..8L,, *4 %, . ~= DEPARTMENT OF HEALTH & HUMAN SERVICES Public Heaw Sewice :, % ~ *+ ‘* %,,.> Food and Drug Administration Rockville MD 20W7 . NDA 50-742 Kenneth R. Brown, M.D. Exetxtive Director Worldwide Regulatory Liaison NOV22 19% Biologics/Vaccines Merck & Co., Inc West Poin~ PA 19486-0004 Dear Dr. Brown: Reference is made to your March 29, 1996 new drug application (NDA) and your resubmission dated October 15, 1996, submitted under section 507 of the Federal Food, Drug, and Cosmetic Act for Tablet STROMECTOL@ (ivexmectin) 6-mg. We acknowledge receipt of your amendments dated April 16, June 28, July 9, 16, 22, and 31, August 23, and 28, and October 4, 1996. This new drug application provides for the treatment of strongyloidiasis and onchocerciasis. We have completed the review of this application, including the submitted draft labeling, and have concluded that adequate information has been presented to demonstrate that the drug product is safe and effective for use as recommended in the enclosed draft labeling. Accordingly, the application is approved effective on the date of this letter. The fml printed labeling (FPL) must be identical to the enclosed draft labeling. Marketing the product with FPL that is not identical to this draft labeling may render the product misbranded and an unapproved new drug. Please submit sixteen copies of the FPL as soon as it is available, in no case more than 30 days after it is printed. Please individually mount ten of the copies on heavy weight paper or similar material. For administrative purposes this submission should be desigmted “FINAL P~TED LABELING” for approved NDA 50-742. Approval of this submission by FDA is not required before the labeling is used. .. Should additional information relating to the safety and effectiveness of the drug become available, revision of that labeling may be required. In addition, please submit three copies of the introductory promotional material that you propose to use for this product. All proposed materials should be submitted in draft or mock-up form, not final print. Please submit one copy to the Division of Anti-Infective Drug Products and two copies of both the promotioml material and the package insert directly to: Page 2 . Food and Drug Administration Division of Drug Marketing, Advertising and Communications, HFD-40 5600 Fishers Lane Rockville, Maryland 20857 Validation of the regulatory methods has not been completed. At the present time, it is the policy of the Center not to withhold approval because the methods are being validated. Nevertheless, we expect your continued cooperation to resolve any problems that may be identified. Please submit one market package of the drug when it is available. We remind you that you must comply with the requirements for an approved NDA set forth under 21 CFR 314.80 and 314.81. If you have any questions, please contact: Ms. Pauline Fogarty Regulatory Health Project Manager (301) 827-2125 -. Sincerely yours, .- w~fq—? David W. Feigal, Jr., .D., M.P.H. Acting Director OffIce of Drug Evaluation IV Center for Drug Evaluation and Research ,“ ENCLOSURE . MEDICAL OFFICER REVIEW OF NDA NDA 50-742 Applicant: Merck Research Laboratories Sumneytown Pike West PoinL PA 19486 Contact: Kenneth Brow MD Executive Director, Regulatory Affh.irs (610) 397-2552 Date of submission: 29 March 1996 CDER stamp date: 1 April 1996 Date review completed: 23 September 1996 Drug identification: Generic name: Ivermectin Proposed trade name: Stromectol@ Molecular formulae: Cq8H7d01g(component HzB1~ C,THnO1d (component HzB,~) Molecular weights: 875.10 (component H2B1J 861.07 (component HzB1~) Chemical name: 5-O-demethyl-22,23 dihydroavennectin A1,;22,23-dihydroavennectin B1,/5-Odemetiyl-25de(metiylpropyl)-22,23dfiy&o-25-(l -methylethyl) avermectin A1~;22,23-dihydroavennectin B1~ structural formula H, H H, Ii canjmentE&R - C% Iverrnectin in the treatment of Strongyloidiasis 1 The disease a. Life cycle b. Clinical manifestations c. Therapy 2. OVerviewof studies submitted in support of indication 3. study004 (Gentiiini) a Study ~ b. Deviations from protocol c. AppIicant’sfindings d MO findings e. Conclusions 4. Study 020 (Dreyer) a. Study summary b. Deviations from protocol c. Applicant’s fidings d. MO findings e. Conclusions 5. Studies O14(Berk) and O16(GamI) a. Study summary b. Deviations from protowl c. AppIieant’s findings d MO iiidings e. COnchsions . 6. WI-10 Study” (Mar@ a. Study summary b. Applicaut’s tidings c. MO findings d. Conehu$ions 7. Submitted literaturcj including Naquira study a Study summq c- Applicant’s findings d MO fhdings e. COxleluskma 8. Statistical considerations 9. overall conclusions 10. Recommendations NDA 50-742 Page 2 Me&an” (Ivennectin) Introduction Pharmacologic category: averrnectin antiparasitic Dosage form: 6-mg scored tablets Route of administration oral Proposed INDICATIONS AND USAGE section Proposed DOSAGE AND ADMINISTRATION section: / NDA 50-742 Page 3 Mcctizm* (Ivernwlin) lntrodudion Materials reviewed: 1. NDA 50-742, volume 1.1 and volumes 1.15-1.27 2. Additional information submitted 9 JuIy 1996. 34 volumes. (included all information previously submitted as a Marketing Authorisation Application w] to the French regulatory authority) 3. Safety Update report submitted31 July 1996. 1 volume. .,,” . NDA SO-742 l’agc1 Mcclti” (lvmncdin) Stiongyioid&iS 1. The disease A. Life eyclc: Srvngyfoidcs stemoralis (heretofm refh to as SS) is a nematodeparatite of UKclam Phasmidia, which also inchxles such humsn parasites as the hookworms (Aneylostoma and Neeator), Tn”choM-ong@s, and Angiosmmg.vlus. These psrasites aIl develop from the egg stagq through f- awecssive Iamal stages, tbcn finally mature to the adultstwe. SS has a lifeeyelewhichis uniqueamongall humanhelminthparasitesin that it has a free- living phase of the Iife-qcle and ean al~ continually reinfd the s&e W The eornplete SS life cycle is demonstrated in the followingdiagrsm: .. ---- .. .. -- ... —- .. LIFE CYCLE OF STRONGYLOIDES . !. PARASITIC $TAGESA~ IN TRANSIT THROUGH , AND IN THE LUNGS * ‘[ TRACT (ESPECIALLY I “n IINTERNAL{ROUW m LUNC @A~hk Q(WTli OR WITHOUT d) ENTERS MUCOSAAND bEpOSfTS fwso WH!CH HATCHAND ES- INTO INTESTINE. 11+~ I[)PASS boWN AND ARk tvAcuAt ED, OR(2) TRANSFORM INTO FILAR lR)Rti LARVAE AND UNbEFl OPTIMUM cOt4tNtfOt4SINTHE so IL FREE -LIVN.lG DEVELOPMENT II%I%%M:A I t.AAY CONTINUE [NDEFIN ITEt_Y I t ?- METMODS OF (NWCTION i. HLAfIttoRM LAtiAE ENTER SKIN IN CONTACT ww SOIL A. FoLLoWING OIRECT nH‘F LARVAL DEVELOPMENT 6. FoLLoWINGFREE-LIvING CYCLE N-4THE SO(L 2.F{LARtFORM LARvAE DEVELOP t3EFoRE LEAVING PATIENT A. FoLLOwI~JG DEPosI moN ON T HE SOIL,ENTER EXPOSED sttm B. ENTER PER(ANAL SKtN AND lNlmATE AUTOINFECTION C ENTER INTESTIIJAL MUCOSA, MIGRATE TO LUNG AND (.::. INITIATE AUTO IWECTION NDA 50-742 Page 3 M&” (iwmuxiin) Slrongyloidiasis . The following aspecls of the life cycle are relevant to clinical trial design: . Theusualmodeof tnmsmkion iaviapemutaneouspenetrationbyaninfectivethird-stagelarva. Oncethis occurs,thepre-patent period (i.e., the time h initial infection to detection of SS larvae in the stool) is roughly 28 days. Therefbre, ifpaticuts are treated for this inf’on but then return to a potentiall@fkclious environment follow-up stool examinations beyond that time point will not be able to distinguish relapse of the original inkction (i.e., drug fdure) fi-omm-infection. lk adult fde is not nearly as prodigious as most of her nematode relatives. It is estimated that the daily egg output of a mature female SS is approximately 30 eggs per day. (Comparatively, an aduh Asearis Iumbricoides fernalelaysapproximately 200,000 eggs per day.) As a resuk detection of SS larvae in the stool of an infected patient requkes concentration methods. The most sensitive method for direct parasite dekcl.ion is the Baermann technique, m which a relatively large stool qxcimen can be processedsuchthatthe larvaeof SS. if press% will migrate out of the specimen This technique was reportedly udlized for all parasitologic specimens processed in the trials submittcxiby the applicant fbr this indication. %c.ause of this low-level shedding of larvae in the stool of the ho% the definition of ‘cure’ should be based on more than a single negative stool examination. There does no+ however, appear to be a umensus in the literature as to how many consecutive negative stools shotdd be requira and over what period of time post- therapy they should be checked. Infection may persist for years, due to the internal autoreirdkction aspect of the life cycle. Larvae hatched in the host intestine may undergo accelerated development into infective third-singe lame while still in the intestinal lumen. These infective larvae then penetrate the gut epitheliumsor @anal skim enter the host circulati~ and repeat the pulmonary + trachea+ gastrointestinal migration which results in the continued presence of sexuaIlymature, parthenogenic finale worms. Elderly adult veterans of the Second World War, particularly those who were prisoners of war in the Pacific theatre of operations, have been diagnosed with strongyloidiasis 30+ years after their initial exposure. Strongyloidiasis can become disseminated if the host becomes immunocompromised. The medical literature documents cases in which quiesent infectionsdkerninate when the host is given immunosuppressive chemotherapy. The
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