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Nouriast Tablets 20 Mg [Non-Proprietary Name] Istradefylline (JAN*) [Applicant] Kyowa Hakko Kirin Co., Ltd

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Nouriast Tablets 20 Mg [Non-Proprietary Name] Istradefylline (JAN*) [Applicant] Kyowa Hakko Kirin Co., Ltd Report on the Deliberation Results March 15, 2013 Evaluation and Licensing Division, Pharmaceutical and Food Safety Bureau Ministry of Health, Labour and Welfare [Brand name] Nouriast Tablets 20 mg [Non-proprietary name] Istradefylline (JAN*) [Applicant] Kyowa Hakko Kirin Co., Ltd. [Date of application] March 30, 2012 [Results of deliberation] In the meeting held on March 8, 2013, the First Committee on New Drugs concluded that the product may be approved and that this result should be reported to the Pharmaceutical Affairs Department of the Pharmaceutical Affairs and Food Sanitation Council. The product is not classified as a biological product or a specified biological product, the re-examination period is 8 years, and neither the drug substance nor the drug product is classified as a poisonous drug or a powerful drug. *Japanese Accepted Name (modified INN) This English version of the Japanese review report is intended to be a reference material to provide convenience for users. In the event of inconsistency between the Japanese original and this English translation, the former shall prevail. The PMDA will not be responsible for any consequence resulting from the use of this English version. Review Report February 22, 2013 Pharmaceuticals and Medical Devices Agency The results of a regulatory review conducted by the Pharmaceuticals and Medical Devices Agency on the following pharmaceutical product submitted for registration are as follows. [Brand name] Nouriast Tablets 20 mg [Non-proprietary name] Istradefylline [Name of applicant] Kyowa Hakko Kirin Co., Ltd. [Date of application] March 30, 2012 [Dosage form/Strength] Film-coated tablets containing 20 mg as Istradefylline per tablet [Application classification] Prescription drug (1) Drug with a new active ingredient [Chemical structure] O CH3 N O CH3 H3C N N O N N O CH3 H C 3 Molecular formula: C20H24N4O4 Molecular weight: 384.43 Chemical name: (E)-8-(3,4-Dimethoxystyryl)-1,3-diethyl-7-methyl-3,7-dihydro-1H-purine-2,6-dione [Items warranting special mention] None [Reviewing office] Office of New Drug II This English version of the Japanese review report is intended to be a reference material to provide convenience for users. In the event of inconsistency between the Japanese original and this English translation, the former shall prevail. The PMDA will not be responsible for any consequence resulting from the use of this English version. Review Results February 22, 2013 [Brand name] Nouriast Tablets 20 mg [Non-proprietary name] Istradefylline [Name of applicant] Kyowa Hakko Kirin Co., Ltd. [Date of application] March 30, 2012 [Results of review] Based on the submitted data, the efficacy of the product in improving the “wearing-off” phenomenon in patients with Parkinson’s disease on levodopa-containing preparations has been demonstrated and its safety is considered acceptable in view of its observed benefits. It is necessary to collect post-marketing information on the occurrence of psychiatric symptoms and dyskinesias, safety and efficacy in patients treated with 40 mg of istradefylline, safety in smokers, patients with hepatic impairment, patients with ischemic heart disease, and patients with respiratory disorders, and potential risks such as psychological dependence and lung toxicity. As a result of its regulatory review, the Pharmaceuticals and Medical Devices Agency has concluded that the product may be approved for the following indication and dosage and administration. [Indication] Improvement of the “wearing-off” phenomenon in patients with Parkinson’s disease on levodopa-containing preparations [Dosage and administration] The product should be used in combination with levodopa-containing preparations. The usual adult dosage is 20 mg of Istradefylline orally administered once daily. According to symptoms, 40 mg of Istradefylline may be orally administered once daily. 3 Review Report (1) January 8, 2013 I. Product Submitted for Registration [Brand name] Nouriast Tablets 20 mg [Non-proprietary name] Istradefylline [Name of applicant] Kyowa Hakko Kirin Co., Ltd. [Date of application] March 30, 2012 [Dosage form/Strength] Film-coated tablets containing 20 mg as Istradefylline per tablet [Proposed indication] Patients with Parkinson’s disease on levodopa-containing preparations with motor complications [Proposed dosage and administration] The product should be used in combination with levodopa-containing preparations. The usual adult dosage is 20 mg of Istradefylline orally administered once daily. The dose should be increased as appropriate according to symptoms and 40 mg of Istradefylline may be orally administered once daily. II. Summary of the Submitted Data and Outline of the Review by the Pharmaceuticals and Medical Devices Agency The data submitted in the application and the outline of a review by the Pharmaceuticals and Medical Devices Agency (PMDA) are as shown below. 1. Origin or history of discovery and usage conditions in foreign countries etc. Parkinson’s disease (PD) is a progressive neurodegenerative disorder characterized by motor deficits including akinesia, rigidity, bradykinesia, and postural reflex impairment, resulting from the degeneration and loss of dopaminergic neurons projecting from the midbrain substantia nigra pars compacta to the striatum and a subsequent reduction in striatal dopamine content. Due to dopamine D2 receptor-mediated inhibitory control over the GABAergic (γ-aminobutyric acid) output of the indirect striato-pallidal pathway, in Parkinson’s disease, there is a reduction in dopamine content, which is considered to lead to a loss of dopaminergic input and an enhanced GABAergic output. A selective adenosine A2A receptor antagonist, istradefylline, antagonizes adenosine A2A receptors expressed in GABAergic medium spiny neurons of the indirect striato-pallidal pathway and is expected to improve the symptoms of Parkinson’s disease by reducing the overactive GABAergic output of the indirect pathway, i.e. through a mechanism different from conventional anti-PD medications that act on dopamine receptors or dopamine-metabolizing enzymes. Although istradefylline was developed as an anti-PD medication by Kyowa Hakko Kirin Co., Ltd. and a new drug application was filed in 2007 in the US, ************************************************************************************* ************************************************************************************** *************************************. As of March 2012, istradefylline is not approved or marketed 4 in any country of the world. In Japan, Kyowa Hakko Kogyo Co., Ltd. (a predecessor of Kyowa Hakko Kirin Co., Ltd.) undertook the development of istradefylline tablets in 1996 and based on the data from Japanese clinical studies etc., a marketing application for istradefylline tablets indicated for “patients with Parkinson’s disease on levodopa- containing preparations with motor complications” has now been submitted. 2. Data relating to quality 2.A Summary of the submitted data 2.A.(1) Drug substance 2.A.(1).1) Characterization The drug substance is a light yellow-green needle crystal and has been characterized by description, powder X-ray diffraction, melting point, thermal analysis, solubility, pH, hygroscopicity, acid dissociation constant (**************), and partition coefficient. The chemical structure of the drug substance has been confirmed by ultraviolet-visible spectroscopy (UV), infrared spectrophotometry (IR), nuclear magnetic resonance spectrometry (1H-NMR,13C-NMR), mass spectrometry (MS), elementary analysis, and single-crystal x-ray crystallography. 2.A.(1).2) Manufacturing process The drug substance is synthesized using ***************************************** ********************************** ************************* as starting materials. ****************************** step and **** step have been defined as critical steps. ****************************. 2.A.(1).3) Control of drug substance The proposed specification for the drug substance include content, description (visual), identification (UV, IR), purity (heavy metals [method 2 of the heavy metals limit test], related substances [liquid chromatography (HPLC)]), residue on ignition (residue on ignition test), ************************, and assay (HPLC). 2.A.(1).4) Stability of drug substance The stability studies conducted on the drug substance are as shown in Table 1. Photostability data showed that the drug substance is photolabile. 5 Table 1. Stability studies on drug substance Study Primary batches Temperature Humidity Storage package Storage period Long-term 25°C 60%RH double polyethylene bags + 60 months 3 production batches fiber drums (protected from Accelerated 40°C 75%RH light) 6 months Based on “Guideline on Evaluation of Stability Data” (PMSB/ELD Notification No. 0603004 dated June 3, 2003, “ICH Q1E Guideline”), a re-test period of 60 months has been proposed for the drug substance when stored in double polyethylene bags within fiber drums, protected from light, at room temperature. 2.A.(2) Drug product 2.A.(2).1) Description and composition of the drug product The drug product is presented as yellow-brown film-coated tablets containing 20 mg of istradefylline per tablet. It contains lactose hydrate, microcrystalline cellulose, crospovidone, polyvinyl alcohol (partially hydrolyzed), magnesium stearate, hypromellose, titanium dioxide, Macrogol 4000, yellow ferric oxide, triacetin, and carnauba wax as excipients. 2.A.(2).2) Manufacturing process The manufacturing process for the drug product consists
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