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Public Assessment Report 29 November 2013 EMA/18511/2014 Committee for Medicinal Products for Human Use (CHMP) Assessment report Para-aminosalicylic acid Lucane International non-proprietary name: para-aminosalicylic acid Procedure No.: EMEA/H/C/002709 Note Assessment report as adopted by the CHMP with all information of a commercially confidential nature deleted. 7 Westferry Circus ● Canary Wharf ● London E14 4HB ● United Kingdom Telephone +44 (0)20 7418 8400 Facsimile +44 (0)20 7418 8416 E -mail [email protected] Website www.ema.europa.eu An agency of the European Union © European Medicines Agency, 2014. Reproduction is authorised provided the source is acknowledged. Table of contents 1. Background information on the procedure .............................................. 5 1.1. Submission of the dossier ...................................................................................... 5 1.2. Manufacturers ...................................................................................................... 6 1.3. Steps taken for the assessment of the product ......................................................... 6 2. Scientific discussion ................................................................................ 8 2.1. Introduction......................................................................................................... 8 2.1.1. Problem statement ............................................................................................ 8 2.1.2. About the product .............................................................................................. 9 2.1.3. Type of application and aspects on development ................................................. 10 2.2. Quality aspects .................................................................................................. 13 2.2.1. Introduction .................................................................................................... 13 2.2.2. Active Substance ............................................................................................. 13 2.2.3. Finished Medicinal Product ................................................................................ 15 2.2.4. Discussion on chemical, pharmaceutical and biological aspects .............................. 17 2.2.5. Conclusions on the chemical, pharmaceutical and biological aspects ...................... 18 2.2.6. Recommendations for future quality development ............................................... 18 2.3. Non-clinical aspects ............................................................................................ 19 2.3.1. Introduction .................................................................................................... 19 2.3.2. Pharmacology ................................................................................................. 19 2.3.3. Pharmacokinetics............................................................................................. 19 2.3.4. Toxicology ...................................................................................................... 20 2.3.5. Ecotoxicity/environmental risk assessment ......................................................... 20 2.3.6. Discussion on non-clinical aspects...................................................................... 21 2.3.7. Conclusion on the non-clinical aspects ................................................................ 22 2.4. Clinical aspects .................................................................................................. 23 2.4.1. Introduction .................................................................................................... 23 2.4.2. Pharmacokinetics............................................................................................. 23 2.4.3. Pharmacodynamics .......................................................................................... 28 2.4.4. Discussion on clinical pharmacology ................................................................... 31 2.4.5. Conclusions on clinical pharmacology ................................................................. 33 2.5. Clinical efficacy .................................................................................................. 34 2.5.1. Dose response studies...................................................................................... 34 2.5.2. Main studies ................................................................................................... 34 2.5.3. Discussion on clinical efficacy ............................................................................ 41 2.5.4. Conclusions on the clinical efficacy ..................................................................... 42 2.6. Clinical safety .................................................................................................... 42 2.6.1. Discussion on clinical safety .............................................................................. 47 2.6.2. Conclusions on the clinical safety ....................................................................... 48 2.7. Pharmacovigilance .............................................................................................. 48 2.8. Risk Management Plan ........................................................................................ 48 2.9. User consultation ............................................................................................... 51 Assessment report EMA/18511/2014 Page 2/55 3. Benefit-Risk Balance.............................................................................. 51 4. Recommendations ................................................................................. 54 Assessment report EMA/18511/2014 Page 3/55 List of abbreviations aNDA abbreviated new drug application Affsaps Agence Française de Sécurité Sanitaire et des Produits de Santé ATU Autorisation Temporaire d'Utilisation AUC area under the serum concentration-time curve Cmax maximum serum concentration DOT directly observed therapy DST drug sensitivity testing ECDC European Centre for Disease Prevention and Control EEA European Economic Area EMA European Medicines Agency EU European Union FDA Food and Drug Administration g gram GI gastrointestinal HIV human immunodeficiency virus h hour IZN isoniazid kg kilogram MAA Marketing Authorisation Application MCC Medicines Control Council MDR-TB multi-drug-resistant tuberculosis mg milligram MIC minimum inhibitory concentration mL millilitre M. tuberculosis Mycobacterium tuberculosis PAS para-aminosalicylic acid PAS Ca calcium PAS PAS-GR PAS gastro-resistant granules PAS K potassium PAS PAS Na sodium PAS PD pharmacodynamic PK pharmacokinetic TB tuberculosis SPC Summary of Product Characteristics STP streptomycin t½ elimination half-life Tmax time to maximum serum concentration μg microgram US United States WHO World Health Organisation XDR-TB Extensively-drug-resistant tuberculosis Assessment report EMA/18511/2014 Page 4/55 1. Background information on the procedure 1.1. Submission of the dossier The applicant Lucane Pharma submitted on 1 March 2012 an application for Marketing Authorisation to the European Medicines Agency (EMA) for PAS-GR, through the centralised procedure falling within the Article 3(1) and point 4 of Annex of Regulation (EC) No 726/2004. The eligibility to the centralised procedure was agreed upon by the EMA/CHMP on 15 February 2012. PAS-GR was designated as an orphan medicinal product EU/3/10/826 on 17 December 2010. PAS- GR was designated as an orphan medicinal product in the following indication: “Treatment of tuberculosis”. The applicant applied for the following indication: “PAS-GR is indicated for the treatment of tuberculosis in combination with other active agents. It is most commonly used in patients with Multi-Drug Resistant TB (MDR-TB) or in situations when primary medication therapy with recommended agents is not possible due to a combination of resistance and/or intolerance. PAS-GR is indicated in adults, infants, children and adolescents.” Following the CHMP positive opinion on this marketing authorisation, the Committee for Orphan Medicinal Products (COMP) reviewed the designation of Para-aminosalicylic acid Lucane as an orphan medicinal product in the approved indication. The outcome of the COMP review can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation. The legal basis for this application refers to: Article 10(a) of Directive 2001/83/EC – relating to applications relying on well-established medicinal use supported by bibliographic literature. The application submitted is composed of administrative information, complete quality data, non- clinical and clinical data based on bibliographic literature substituting all non-clinical tests and clinical studies. Information on Paediatric requirements Not applicable Information relating to orphan market exclusivity Similarity Pursuant to Article 8 of Regulation (EC) No. 141/2000 and Article 3 of Commission Regulation (EC) No 847/2000, the applicant did not submit a critical report addressing the possible similarity with authorised orphan medicinal products because there is no authorised orphan medicinal product for a condition related to the proposed indication. Assessment report EMA/18511/2014 Page 5/55 Derogations from market exclusivity Not applicable New active Substance status The applicant did not request that the active substance para-aminosalicylic acid contained in the above medicinal product to be considered as a
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