Virology competitors updates from CHMP Meeting Minutes

Initial applications Opinions

• Regkirona (regdanvimab) (NAS) - Celltrion Healthcare
  • Indication: Treatment of COVID-19
  • The Committee confirmed that all issues previously identified in this application had been addressed.
  • The Committee adopted a positive opinion recommending the granting of a marketing authorisation.
• Ronapreve (casirivimab / imdevimab) (NAS) – Roche
  • Indication: prevention and treatment of COVID-19
  • The Committee confirmed that all issues previously identified in this application had been addressed.
  • The Committee adopted a positive opinion recommending the granting of a marketing authorisation
  • The CHMP noted the letter of recommendation dated 10 November 2021.

Post-authorisation issues

• Spikevax (COVID-19 mRNA vaccine (nucleoside-modified) - Moderna
  • To update sections 2, 4.2, 4.8, 5.1, 6.5 and 6.6 of the SmPC to include a booster dose for Spikevax, based on new clinical data from studies mRNA-1273-P201, a Phase 2a, Randomized, Observer-Blind, Placebo-Controlled, Dose-Confirmation Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1273 SARS-CoV-2 Vaccine in Adults Aged 18 Years and Older (NCT04405076), mRNA-1273-P301, an ongoing Phase 3, Randomized, Stratified, Observer-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Immunogenicity of mRNA-1273 SARS-CoV-2 Vaccine in Adults Aged 18 Years and Older (NCT04470427) and DMID 21-0012, a Phase 1/2 Study of Delayed Heterologous SARS-CoV-2 Vaccine Dosing (Boost) After Receipt of EUA Vaccines (NCT04889209). The package leaflet is updated accordingly.
  • At an extraordinary CHMP meeting on 25 October 2021, the CHMP discussed this variation.
  • On 25 October 2021, the Committee adopted a positive opinion by majority (28 positive votes out of 30 votes) together with the CHMP Assessment Report and translation timetable.

Referral procedures

• Molnupiravir - Merck
  • Indication: Treatment of coronavirus disease 2019 (COVID-19)
  • Request for CHMP opinion on potential use of molnupiravir for the treatment of COVID-19 in adult patients.
  • The CHMP adopted a list of questions with a specific timetable.

AOB topic

Update on COVID-19

• Sotrovimab
  • Indication: Treatment of coronavirus disease 2019 (COVID-19)
  • The CHMP adopted the interim opinion on the 4th rolling review.
• COVID-19 vaccine
  • Indication: Active immunisation to prevent COVID-19 caused by SARS-CoV-2, in individuals 18 years of age and older.
  • The CHMP adopted the interim opinion on the 2nd rolling review.
• COVID-19 vaccine (NVX-CoV2373)
  • Indication: Prevention of COVID-19
  • The CHMP noted the update and adopted a list of questions.
• Bamlanivimab LILLY (bamlanivimab) - Eli Lilly
  • Indication: treatment of COVID-19 in combination with etesevimab
  • The CHMP noted the withdrawal of rolling review.
• Etesevimab LILLY (etesevimab) - Eli Lilly
  • Indication: Treatment of COVID-19 in combination with bamlanivimab
  • The CHMP noted the withdrawal of rolling review.

Renewals of Marketing Authorisations for unlimited validity

• Emtricitabine / tenofovir disoproxil - KRKA, (Generic)
  • Positive Opinion adopted by consensus together with the CHMP assessment report and translation timetable.
  • The CHMP believed the renewal of the marketing authorisation can be granted with unlimited validity.

EPARs / WPARs

• Bamlanivimab LILLY (bamlanivimab) (NAS) - Eli Lilly
  • Indication: treatment of COVID-19 in combination with etesevimab
• Etesevimab LILLY (etesevimab) (NAS) - Eli Lilly
  • Indication: treatment of COVID-19 in combination with bamlanivimab

CHMP assessed procedures scope: Pharmaceutical aspects

• COMIRNATY (tozinameran) - BioNTech
  • Positive Opinion adopted by consensus on 28.10.2021
• COVID-19 Vaccine Janssen (adenovirus type 26 encoding the SARS-CoV-2 spike glycoprotein) - Janssen-Cilag International
  • Positive Opinion adopted by consensus on 21.10.2021.
• Vaxzevria (COVID 19 Vaccine (ChAdOx1 S [recombinant]) - AstraZeneca
  • Positive Opinion adopted by consensus on 03.11.2021.

CHMP assessed procedures scope: Non-Clinical and Clinical aspects

• REKAMBYS (rilpivirine) - Janssen-Cilag
  • “Update of section 4.4 of the SmPC in order to amend an existing warning on section post-injections reactions, based on the availability of new information from ongoing phase 3/3b clinical trials. Section 2 of the Package Leaflet is updated accordingly. In addition, the MAH took the opportunity to implement some minor editorial changes.”
  • Request for Supplementary Information adopted on 21.10.2021.

• Spikevax (covid-19 mRNA vaccine (nucleoside-modified)) - Moderna
  • To update sections 2, 4.2, 4.4, 4.8, 5.1, 6.5 and 6.6 of the SmPC to include a booster dose for Spikevax, based on new clinical data from studies mRNA-1273-P201, a Phase 2a, Randomized, Observer-Blind, Placebo-Controlled, Dose-Confirmation Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1273 SARS-CoV-2 Vaccine in Adults Aged 18 Years and Older (NCT04405076), mRNA-1273-P301, an ongoing Phase 3, Randomized, Stratified, Observer-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Immunogenicity of mRNA-1273 SARS-CoV-2 Vaccine in Adults Aged 18 Years and Older (NCT04470427) and DMID 21-0012, a Phase 1/2 Study of Delayed Heterologous SARS-CoV-2 Vaccine Dosing (Boost) After Receipt of EUA Vaccines (NCT04889209). The labelling and the package leaflet are updated accordingly.” Opinion adopted on 25.10.2021.

CHMP-PRAC assessed procedures

• Trogarzo (ibalizumab) - Theratechnologies
  • “Submission of an updated RMP version 2.0 in order to reflect the new timelines of the PROMISE study and to align the information included in the RMP with the latest PSUR. As the PROMISE study is a condition of the Trogarzo marketing authorisation, the delayed start date results in a change to Annex II of the marketing authorisation. The date for providing the final study report is changing.”
  • Opinion adopted on 28.10.2021.
  • Request for Supplementary Information adopted on 30.09.2021.

PRAC assessed procedures

• Spikevax (covid-19 mrna vaccine (nucleoside-modified)) - Moderna
  • “Grouped variation to address PRAC requests raised in the 3rd Spikevax Monthly Safety Summary Report (MSSR) procedure (EMEA/H/C/005791/MEA/011.2): - Update of section 4.8 of the SmPC to include details regarding time to onset and duration of the delayed injection site reactions. The Package Leaflet is updated accordingly.
  • Update of section 4.8 of the SmPC to include “diarrhoea” as an adverse reaction, with the frequency ‘Common’. The Package Leaflet is updated accordingly. In addition, the Marketing Authorisation Holder (MAH) took the opportunity to make minor editorial changes.”
  • Opinion adopted on 28.10.2021. Request for Supplementary Information adopted on 02.09.2021, 08.07.2021.

Unclassified procedures and worksharing procedures of type I variations

• Kivexa, Triumeq, Trizivir, Ziagen - ViiV Healthcare
  • Opinion adopted on 11.11.2021. Request for Supplementary Information adopted on 09.09.2021.
  • Positive Opinion adopted by consensus on 11.11.2021.

CHMP assessed procedures scope: Non-Clinical and Clinical aspects

• REKAMBYS (rilpivirine) - Janssen-Cilag
  • “Update of sections 4.8 and 5.1 of the SmPC in order to update efficacy and safety information based on week 96 results from the clinical study 207966 (ATLAS-2M). This is a open-label, randomized, Phase IIIb trial to demonstrate non-inferior antiviral activity and safety of CAB + RPV Q8W compared with CAB + RPV Q4W. Supporting Cabotegravir (CAB) Long-acting Injectable (LA) + Rilpivirine (RPV) LA every 2 months (Q8W) dosing regimen for the treatment of HIV-1 infection.”
• Vaxzevria (COVID 19 Vaccine (ChAdOx1 S [recombinant]) - AstraZeneca
  • “Submission of the final report from MS1222-0004 study "Binding of PF4 to AZD1222 and Purified ChAdOx1" and the Greinacher et al (Greinacher et al 2021) paper, titled "A prothrombotic thrombocytopenic disorder resembling heparin-induced thrombocytopenia following Coronavirus-19 vaccination" listed as a category 3 study in the RMP.”
• Vocabria (cabotegravir) – ViiV Healthcare
  • “Update of sections 4.8 and 5.1 of the SmPC in order to update efficacy and safety information based on week 96 results from the clinical study 207966 (ATLAS-2M). This is an open-label, randomized, Phase IIIb trial to demonstrate non-inferior antiviral activity and safety of CAB + RPV Q8W compared with CAB + RPV Q4W. Supporting Cabotegravir (CAB) Long-acting Injectable (LA) + Rilpivirine (RPV) LA every 2 months (Q8W) dosing regimen for the treatment of HIV-1 infection.”
• Combivir, Kivexa, Trizivir - ViiV Healthcare B.V.
  • “Update of section 5.2 of the SmPC in order to add new information on the elimination half-life of lamivudine, based on final results from studies 204993 and 204994. Study 204993 was a phase I, relative oral bioavailability study of different fixed dose combinations of dolutegravir and lamivudine in healthy subjects. Study 204994 was an open-label, randomized, single dose, crossover, bioequivalence study of fixed-dose combination tablet(s) of dolutegravir and lamivudine versus dolutegravir and lamivudine single entities and food effect assessment in healthy volunteers. In addition, the MAH took the opportunity to bring the PI in line with the latest QRD template version 10.2 and to introduce minor editorial changes.”

Fonte: minutes-chmp-meeting-8-11-november-2021_en.pdf