09 July 2021 EMA/CHMP/350170/2021 Human Medicines Division Committee for medicinal products for human use (CHMP) Minutes for the meeting on 17-20 May 2021 Chair: Harald Enzmann – Vice-Chair: Bruno Sepodes Disclaimers Some of the information contained in this set of minutes 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, the minutes 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 minutes 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). Official address Domenico Scarlattilaan 6 ● 1083 HS Amsterdam ● The Netherlands Address for visits and deliveries Refer to www.ema.europa.eu/how-to-find-us Send us a question Go to www.ema.europa.eu/contact Telephone +31 (0)88 781 6000 An agency of the European Union © European Medicines Agency, 2021. Reproduction is authorised provided the source is acknowledged. Table of contents 1. Introduction 8 1.1. Welcome and declarations of interest of members, alternates and experts ............ 8 1.2. Adoption of agenda ................................................................................................ 8 1.3. Adoption of the minutes ......................................................................................... 8 2. Oral Explanations 9 2.1. Pre-authorisation procedure oral explanations ....................................................... 9 2.1.1. eflornithine / sulindac - Orphan - EMEA/H/C/005043 ..................................................... 9 2.1.2. Ozawade - pitolisant - EMEA/H/C/005117 .................................................................... 9 2.1.3. tanezumab - EMEA/H/C/005189 ................................................................................ 9 2.2. Re-examination procedure oral explanations ....................................................... 10 2.3. Post-authorisation procedure oral explanations ................................................... 10 2.3.1. Keytruda - pembrolizumab - EMEA/H/C/003820/II/0097 ............................................. 10 2.3.2. Veklury – remdesivir - EMEA/H/C/005622/R/0015 ...................................................... 10 2.4. Referral procedure oral explanations ................................................................... 10 3. Initial applications 11 3.1. Initial applications; Opinions ................................................................................ 11 3.1.1. Bylvay - odevixibat - Orphan - EMEA/H/C/004691 ...................................................... 11 3.1.2. Icatibant Accord - icatibant - EMEA/H/C/005083 ........................................................ 11 3.1.3. Imcivree - setmelanotide - Orphan - EMEA/H/C/005089 .............................................. 12 3.1.4. Klisyri - tirbanibulin mesilate - EMEA/H/C/005183 ...................................................... 12 3.1.5. Ozawade - pitolisant - EMEA/H/C/005117 .................................................................. 13 3.1.6. Ryeqo - relugolix / estradiol / norethisterone acetate - EMEA/H/C/005267 ..................... 13 3.1.7. Skysona - elivaldogene autotemcel - Orphan - ATMP - EMEA/H/C/003690 ...................... 14 3.1.8. Verquvo - vericiguat - EMEA/H/C/005319 .................................................................. 14 3.2. Initial applications; List of outstanding issues (Day 180; Day 120 for procedures with accelerated assessment timetable) ...................................................................... 15 3.2.1. ranibizumab - EMEA/H/C/005545 ............................................................................. 15 3.2.2. roxadustat - EMEA/H/C/004871 ............................................................................... 15 3.2.3. bevacizumab - EMEA/H/C/005433 ............................................................................ 16 3.2.4. avalglucosidase alfa - Orphan - EMEA/H/C/005501 ..................................................... 16 3.2.5. tanezumab - EMEA/H/C/005189 .............................................................................. 16 3.2.6. sitagliptin - EMEA/H/C/005598 ................................................................................ 16 3.2.7. sugammadex - EMEA/H/C/005403 ........................................................................... 17 3.2.8. tafasitamab - Orphan - EMEA/H/C/005436 ................................................................ 17 3.3. Initial applications; List of questions (Day 120; Day 90 for procedures with accelerated assessment timetable) ...................................................................... 17 Committee for medicinal products for human use (CHMP) EMA/CHMP/350170/2021 Page 2/60 3.3.1. sotorasib - EMEA/H/C/005522 ................................................................................. 17 3.3.2. voxelotor - Orphan - EMEA/H/C/004869 .................................................................... 18 3.3.3. amivantamab - EMEA/H/C/005454 ........................................................................... 18 3.3.4. sapropterin - EMEA/H/C/005646 .............................................................................. 18 3.3.5. teriparatide - EMEA/H/C/005793 .............................................................................. 18 3.3.6. semaglutide - EMEA/H/C/005422 ............................................................................. 19 3.4. Update on on-going initial applications for Centralised procedure ........................ 19 3.4.1. betaine anhydrous - EMEA/H/C/005637 .................................................................... 19 3.4.2. dabigatran etexilate - EMEA/H/C/005639 .................................................................. 19 3.4.3. pralsetinib - EMEA/H/C/005413 ............................................................................... 19 3.4.4. insulin human (rDNA) - EMEA/H/C/005331 ................................................................ 20 3.4.5. lenadogene nolparvovec - Orphan - ATMP - EMEA/H/C/005047 .................................... 20 3.4.6. metformin hydrochloride / sitagliptin hydrochloride monohydrate - EMEA/H/C/005678 ..... 20 3.5. Re-examination of initial application procedures under Article 9(2) of Regulation no 726/2004 ............................................................................................................. 20 3.6. Initial applications in the decision-making phase ................................................. 21 3.7. Withdrawals of initial marketing authorisation application .................................. 21 4. Extension of marketing authorisation according to Annex I of Commission Regulation (EC) No 1234/2008 21 4.1. Extension of marketing authorisation according to Annex I of Commission Regulation (EC) No 1234/2008; Opinion ................................................................................ 21 4.1.1. Bortezomib Accord - bortezomib - EMEA/H/C/003984/X/0023 ...................................... 21 4.1.2. Cosentyx - secukinumab - EMEA/H/C/003729/X/0067 ................................................. 21 4.2. Extension of marketing authorisation according to Annex I of Commission Regulation (EC) No 1234/2008; Day 180 list of outstanding issues ....................................... 22 4.2.1. Deltyba - delamanid - Orphan - EMEA/H/C/002552/X/0046/G ...................................... 22 4.2.2. Rinvoq - upadacitinib - EMEA/H/C/004760/X/0006/G .................................................. 22 4.2.3. Volibris - ambrisentan - EMEA/H/C/000839/X/0061/G ................................................. 23 4.2.4. Vosevi - sofosbuvir / velpatasvir / voxilaprevir - EMEA/H/C/004350/X/0045/G ................ 23 4.3. Extension of marketing authorisation according to Annex I of Commission Regulation (EC) No 1234/2008; Day 120 List of question ...................................................... 24 4.3.1. Ozempic - semaglutide - EMEA/H/C/004174/X/0021 ................................................... 24 4.4. Update on on-going extension application according to Annex I of Commission Regulation (EC) No 1234/2008 ............................................................................ 24 4.5. Re-examination procedure of extension of marketing authorisation according to Annex I of Commission Regulation (EC) No 1234/2008 ....................................... 24 Committee for medicinal products for human use (CHMP) EMA/CHMP/350170/2021 Page 3/60 5. Type II variations - variation of therapeutic indication procedure according to Annex I of Commission Regulation (EC) No 1234/2008 24 5.1. Type II variations - variation of therapeutic indication procedure according to Commission Regulation (EC) No 1234/2008; Opinions or Requests for