6 November 2017 EMA/CHMP/721012/2017 Inspections, Human Medicines Pharmacovigilance and Committees Division Committee for medicinal products for human use (CHMP) Draft agenda for the meeting on 06-09 November 2017 Chair: Tomas Salmonson – Vice-Chair: Harald Enzmann 06 November 2017, 13:00 – 19:30, room 2A 07 November 2017, 08:30 – 19:30, room 2A 08 November 2017, 08:30 – 19:30, room 2A 09 November 2017, 08:30 – 15:00, room 2A Health and safety information In accordance with the Agency’s health and safety policy, delegates are to be briefed on health, safety and emergency information and procedures prior to the start of the meeting. Disclaimers Some of the information contained in this agenda is considered commercially confidential or sensitive and therefore not disclosed. With regard to intended therapeutic indications or procedure scopes listed against products, it must be noted that these may not reflect the full wording proposed by applicants and may also vary during the course of the review. Additional details on some of these procedures will be published in the CHMP meeting highlights once the procedures are finalised and start of referrals will also be available. Of note, this agenda is a working document primarily designed for CHMP members and the work the Committee undertakes. Note on access to documents Some documents mentioned in the agenda cannot be released at present following a request for access to documents within the framework of Regulation (EC) No 1049/2001 as they are subject to on- going procedures for which a final decision has not yet been adopted. They will become public when adopted or considered public according to the principles stated in the Agency policy on access to documents (EMA/127362/2006). 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5520 Send a question via our website www.ema.europa.eu/contact An agency of the European Union © European Medicines Agency, 2017. Reproduction is authorised provided the source is acknowledged. Table of contents 1. Introduction 7 1.1. Welcome and declarations of interest of members, alternates and experts ............ 7 1.2. Adoption of agenda ................................................................................................ 7 1.3. Adoption of the minutes ......................................................................................... 7 2. Oral Explanations 7 2.1. Pre-authorisation procedure oral explanations ....................................................... 7 2.1.1. rurioctocog alfa pegol - EMEA/H/C/004195 ................................................................... 7 2.1.2. plitidepsin - Orphan - EMEA/H/C/004354 ...................................................................... 7 2.1.3. semaglutide - EMEA/H/C/004174 ................................................................................. 8 2.1.4. d-biotin - EMEA/H/C/004153 ....................................................................................... 8 2.1.5. rucaparib - Orphan - EMEA/H/C/004272 ....................................................................... 8 2.2. Re-examination procedure oral explanations ......................................................... 8 2.2.1. Fanaptum - iloperidone - EMEA/H/C/004149 ................................................................. 8 2.2.2. Onzeald - etirinotecan pegol - EMEA/H/C/003874 .......................................................... 8 2.3. Post-authorisation procedure oral explanations ..................................................... 9 2.4. Referral procedure oral explanations ..................................................................... 9 3. Initial applications 9 3.1. Initial applications; Opinions .................................................................................. 9 3.1.1. rurioctocog alfa pegol - EMEA/H/C/004195 ................................................................... 9 3.1.2. darunavir - EMEA/H/C/004273 .................................................................................... 9 3.1.3. darunavir - EMEA/H/C/004891 .................................................................................... 9 3.1.4. benralizumab - EMEA/H/C/004433 ............................................................................. 10 3.1.5. fulvestrant - EMEA/H/C/004649 ................................................................................ 10 3.1.6. prasterone - EMEA/H/C/004138 ................................................................................ 10 3.1.7. budesonide - Orphan - EMEA/H/C/004655 .................................................................. 10 3.1.8. letermovir - Orphan - EMEA/H/C/004536 .................................................................... 10 3.1.9. bevacizumab - EMEA/H/C/004728 ............................................................................. 11 3.1.10. ocrelizumab - EMEA/H/C/004043 ............................................................................... 11 3.1.11. semaglutide - EMEA/H/C/004174 ............................................................................... 11 3.1.12. rucaparib - Orphan - EMEA/H/C/004272 ..................................................................... 11 3.2. Initial applications; List of outstanding issues (Day 180; Day 120 for procedures with accelerated assessment timetable) ...................................................................... 12 3.2.1. expanded human allogeneic mesenchymal adult stem cells extracted from adipose tissue - Orphan - ATMP - EMEA/H/C/004258 .......................................................................... 12 3.2.2. trastuzumab - EMEA/H/C/002575 .............................................................................. 12 3.2.3. andexanet alfa - EMEA/H/C/004108 ........................................................................... 12 Committee for medicinal products for human use (CHMP) EMA/CHMP/721012/2017 Page 2/34 3.2.4. trastuzumab - EMEA/H/C/004361 .............................................................................. 12 3.2.5. binimetinib - EMEA/H/C/004052 ................................................................................ 12 3.2.6. ertugliflozin / metformin hydrochloride - EMEA/H/C/004314 ......................................... 13 3.2.7. ertugliflozin - EMEA/H/C/004315 ............................................................................... 13 3.2.8. ertugliflozin / sitagliptin - EMEA/H/C/004313 .............................................................. 13 3.3. Initial applications; List of questions (Day 120; Day 90 for procedures with accelerated assessment timetable) ...................................................................... 13 3.3.1. glycopyrronium / formoterol fumarate dihydrate - EMEA/H/C/004245 ............................ 13 3.3.2. bictegravir / emtricitabine / tenofovir alafenamide - EMEA/H/C/004449.......................... 13 3.3.3. dapivirine - Article 58 - EMEA/H/W/002168................................................................. 14 3.3.4. deferiprone - EMEA/H/C/004710 ................................................................................ 14 3.3.5. lesinurad / allopurinol - EMEA/H/C/004412 ................................................................. 14 3.3.6. pacritinib - Orphan - EMEA/H/C/004793 ..................................................................... 14 3.3.7. botulinum toxin type A - EMEA/H/C/004587 ................................................................ 14 3.3.8. trastuzumab - EMEA/H/C/004463 .............................................................................. 14 3.3.9. meropenem / vaborbactam - EMEA/H/C/004669 ......................................................... 15 3.4. Update on on-going initial applications for Centralised procedure ........................ 15 3.4.1. betrixaban - EMEA/H/C/004309 ................................................................................. 15 3.4.2. velmanase alfa - Orphan - EMEA/H/C/003922 ............................................................. 15 3.4.3. neratinib - EMEA/H/C/004030 ................................................................................... 15 3.4.4. insulin glargine - EMEA/H/C/004280 .......................................................................... 15 3.5. Re-examination of initial application procedures under Article 9(2) of Regulation no 726/2004 ............................................................................................................. 16 3.5.1. Fanaptum - iloperidone - EMEA/H/C/004149 ............................................................... 16 3.5.2. Onzeald - etirinotecan pegol - EMEA/H/C/003874 ........................................................ 16 3.6. Initial applications in the decision-making phase ................................................. 16 3.7. Withdrawals of initial marketing authorisation application .................................. 16 3.7.1. bevacizumab - EMEA/H/C/004360 ............................................................................. 16 4. Extension of marketing authorisation according to Annex I of Commission Regulation (EC) No 1234/2008 17 4.1. Extension of marketing authorisation according to Annex I of Commission Regulation (EC) No 1234/2008; Opinion ................................................................................ 17 4.1.1. Orkambi - lumacaftor / ivacaftor - EMEA/H/C/003954/X/0020 ......................................