Agreed PIPs for FDCs for the treatment of HIV-1 infection
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1 Agreed PIPs for FDCs for the treatment of HIV-1 infection Introduction for the HIV FDC Expert meeting Presented by Andrea Ecker on 10 November 2015 Scientific Officer, Paediatric Medicines Office, Human Medicines Research and Development Support Division An agency of the European Union
2 General comments PDCO reviews FDCs for which the applicant pursues an EU marketing authorisation in adults for a new product the legal obligation to complete the PIP is triggered when the product is authorised in adults in some instances new active substances seem to be currently developed only in FDCs, not individually each PIP is assessed individually on its own merits this presentation only includes public information 1
3 HIV FDCs with an agreed PIP or waiver PIP agreed in PIP completed (completion date) FTC/RPV/TDF (Eviplera) * 2010 No (2019) EVG/FTC/TDF/COBI (Stribild) * 2011 No (2020) LPV/r (oral solution) (Kaletra) 2011 Yes (2015) LPV/r/3TC 2012 N/A (full waiver) DTG/ABC/3TC (Triumeq) * 2012 No (2019) DRV/COBI (Rezolsta) 2013 No (2021) LPV/3TC/r/AZT * 2013 N/A (full waiver) RAL/3TC (Dutrebris) 2014 Yes (2014) EVG/COBI/FTC/TAF* 2014 No (2017) ATV/COBI (Evotaz) 2014 No (2019) FTC/TAF 2015 No (2020) FTC/TAF/RPV * 2015 No (2021) 2 *single-tablet regimen blue font = authorised in adults
4 HIV FDCs with an agreed PIP or waiver age range PIP agreed in Current paediatric authorisation Age range of PIP FTC/RPV/TDF (Eviplera) * 2010 No > 6 years EVG/FTC/TDF/COBI (Stribild) * 2011 No > 6 years LPV/r (oral solution) (Kaletra) 2011 > 2 yrs 14 days - <2 years DTG/ABC/3TC (Triumeq) * 2012 > 12 yrs (> 40 kg) > 2 years DRV/COBI (Rezolsta) 2013 No > 3 years RAL/3TC (Dutrebris) 2014 > 6 yrs (> 30 kg) > 6 years (>30 kg) EVG/COBI/FTC/TAF* 2014 N/A > 6 years ATV/COBI (Evotaz) 2014 No > 3 months FTC/TAF 2015 N/A > 4 weeks FTC/TAF/RPV * 2015 N/A > 4 weeks 3
5 HIV FDCs with an agreed PIP or waiver age range PIP agreed in Current paediatric authorisation Age range of PIP FTC/RPV/TDF (Eviplera) * 2010 No > 6 years EVG/FTC/TDF/COBI (Stribild) * 2011 No > 6 years LPV/r (oral solution) (Kaletra) 2011 > Q1/Q2: 2 yrs Which 14 age days range - <2 for years DTG/ABC/3TC (Triumeq) * 2012 > 12 yrs (> 40 kg) > 2 years which product? DRV/COBI (Rezolsta) 2013 No > 3 years Prioritisation criteria? RAL/3TC (Dutrebris) 2014 > 6 yrs (> 30 kg) > 6 years (>30 kg) EVG/COBI/FTC/TAF* 2014 N/A > 6 years ATV/COBI (Evotaz) 2014 No > 3 months FTC/TAF 2015 N/A > 4 weeks FTC/TAF/RPV * 2015 N/A > 4 weeks 4
6 Development plans Quality Age range of Agreed quality measure (intended age PIP [yrs]) FTC/RPV/TDF (Eviplera) * > 6 years age appropriate film-coated tablet (6-12) EVG/FTC/TDF/COBI (Stribild) * > 6 years age appropriate oral solid dosage form LPV/r (oral solution) (Kaletra) 14 days - <2 yrs n/a DTG/ABC/3TC (Triumeq) * > 2 years dispersible tablet DRV/COBI (Rezolsta) > 3 years age-appropriate oral solid dosage form and ageappropriate oral liquid dosage form (3-12) RAL/3TC (Dutrebris) > 6 yrs (>30 kg) n/a EVG/COBI/FTC/TAF* > 6 years age-appropriate film-coated tablet (6-12) age-appropriate oral solid dosage form (3 mo-18) ATV/COBI (Evotaz) > 3 months film-coated tablet (adolescents >40 kg) FTC/TAF > 4 weeks film-coated tablet (6-12) age-appropriate oral formulation (<6) FTC/TAF/RPV * > 4 weeks film-coated tablet (6-12) age-appropriate oral formulation (<6) 5
7 Development plans Quality Age range of Agreed quality measure (intended age PIP [yrs]) FTC/RPV/TDF (Eviplera) * > 6 years age appropriate film-coated tablet (6-12) EVG/FTC/TDF/COBI (Stribild) * > 6 years age appropriate oral solid dosage form Q3-5: Feasibility (multiple LPV/r (oral solution) (Kaletra) 14 days - <2 yrs n/a DTG/ABC/3TC (Triumeq) * > 2 years FDCs dispersible in youngest tablet children, DRV/COBI (Rezolsta) Q7: What are desired > 3 years AAFs? age-appropriate diverging oral solid from dosage individual form and ageappropriate active oral substance liquid dosage dosing, form age (3-12) RAL/3TC (Dutrebris) > 6 yrs (>30 kg) n/a cut-offs)? EVG/COBI/FTC/TAF* > 6 years age-appropriate film-coated tablet (6-12) ATV/COBI (Evotaz) > 3 months film-coated tablet (adolescents >40 kg) Q6: use of the adult age-appropriate oral solid dosage form (3 mo-18) FTC/TAF formulation in > adolescents 4 weeks film-coated tablet (6-12) age-appropriate oral formulation (<6) FTC/TAF/RPV * > 4 weeks film-coated tablet (6-12) age-appropriate oral formulation (<6) 6
8 Development plans Clinical Age range of PIP Clinical studies in FTC/RPV/TDF (Eviplera) * > 6 years 6-18 yrs EVG/FTC/TDF/COBI (Stribild) * > 6 years 6-18 yrs LPV/r (oral solution) (Kaletra) 14 days - <2 yrs 14 weeks 37 months DTG/ABC/3TC (Triumeq) * > 2 years 2-12 yrs DRV/COBI (Rezolsta) > 3 years 3-18 yrs RAL/3TC (Dutrebris) > 6 yrs (>30 kg) healthy adults only EVG/COBI/FTC/TAF* > 6 years 6-18 yrs ATV/COBI (Evotaz) > 3 months healthy adults only FTC/TAF > 4 weeks 4 weeks 18 yrs FTC/TAF/RPV * > 4 weeks healthy adults only 7
9 Development plans Clinical Age range of PIP Clinical studies in FTC/RPV/TDF (Eviplera) * > 6 years 6-18 yrs EVG/FTC/TDF/COBI (Stribild) * > 6 years 6-18 yrs Q3-5: Feasibility (multiple LPV/r (oral solution) (Kaletra) 14 days - <2 yrs 14 weeks 37 months DTG/ABC/3TC (Triumeq) * > 2 years FDCs in 2-12 youngest yrs children, Q7: Acceptability/palatability DRV/COBI (Rezolsta) > 3 years diverging 3-18 from yrs individual data in children? RAL/3TC (Dutrebris) > 6 yrs (>30 kg) active healthy substance adults dosing, only age EVG/COBI/FTC/TAF* > 6 years 6-18 cut-offs)? yrs ATV/COBI (Evotaz) > 3 months healthy adults only FTC/TAF Q6: Development > 4 weeks in 4 weeks 18 yrs FTC/TAF/RPV * adolescents > 4 weeks healthy adults only 8
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