Virology Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) meeting on 24-26 April 2023 released on the 06th of July 2023.

Minutes from the EMA’s Committee for Medicinal Products for Human Use (CHMP) meeting on 24-26 April 2023 released on the 06th of July 2023. Items of interest listed below: 

Re-examination of initial application procedures under Article 9(2) of Regulation no 726/2004

Lagevrio - molnupiravir - Merck Sharp & Dohme B.V.; treatment of coronavirus disease 2019 (COVID-19)

• The CHMP adopted the re-examination timetable. On Jun 21, 2023 Merck (MSD) submitted a letter to the Committee for Medicinal Products for Human Use (CHMP) announcing their decision to withdraw the marketing authorization application of LAGEVRIO (oral, direct-acting antiviral, 800 mg LAGEVRIO BID for 5 days, generic name molnupiravir) for the treatment of COVID-19 in adults who do not require supplemental oxygen and who are at increased risk of developing severe COVID-19 in the European Union. (Source: EMA website, Letter)

Type II variations - variation of therapeutic indication procedure according to Commission Regulation (EC) No 1234/2008; Opinions or Requests for supplementary information

Ronapreve - casirivimab / imdevimab - Roche Registration GmbH

• Extension of indication to include treatment of COVID-19 in adults and adolescents aged 12 years and older weighing at least 40 kg and receiving supplemental oxygen, who have a negative SARS-CoV-2 antibody test result for Ronapreve; as a consequence, sections 4.1, 4.2, 4.4, 4.8, 4.9, 5.1, 5.2 and 6.6 of the SmPC are updated. The variation leads to amendments to the Summary of Product Characteristics, Labelling and Package Leaflet and to the Risk Management Plan (RMP).”, Request for 1 year of market protection for a new indication (Article 14(11) of Regulation (EC) 726/2004)
• The Committee confirmed that all issues previously identified in this application had been addressed. The Committee adopted a positive opinion by consensus together with the CHMP Assessment Report and translation timetable.  The summary of opinion was circulated for information.

RENEWALS OF MARKETING AUTHORISATIONS OUTCOMES

B.2.2.  Renewals of Marketing Authorisations for unlimited validity

Delstrigo - doravirine / lamivudine / tenofovir disoproxil - Merck Sharp & Dohme B.V.,

• Positive Opinion adopted by consensus together with the CHMP assessment report and translation timetable.
• Based on the review of the available information, the CHMP was of the opinion that the renewal of the marketing authorisation can be granted with unlimited validity.

Pifeltro - doravirine - Merck Sharp & Dohme B.V.,

• Positive Opinion adopted by consensus together with the CHMP assessment report and translation timetable.
• Based on the review of the available information, the CHMP was of the opinion that the renewal of the marketing authorisation can be granted with unlimited validity.

B.6.8. CHMP assessed procedures scope: Pharmaceutical aspects

Comirnaty - tozinameran - BioNTech Manufacturing GmbH

Nuvaxovid - Covid-19 vaccine (recombinant, adjuvanted) - Novavax CZ, a.s.,

Spikevax - elasomeran - Moderna Biotech Spain, S.L.,

VidPrevtyn Beta - SARS-CoV-2, B.1.351 variant, prefusion Spike delta TM protein - Sanofi Pasteur

B.6.9. CHMP assessed procedures scope: Non-Clinical and Clinical aspects

Paxlovid - nirmatrelvir / ritonavir - Pfizer Europe MA EEIG

• “Grouped application comprising two type II variations as follows:
  • Update of section 4.3 of the SmPC in order to add ‘Mineralocorticoid receptor antagonists: finerenone’ and ‘Opioid antagonists: naloxegol’ under Medicinal products that are highly dependent on CYP3A for clearance and for which elevated plasma concentrations are associated with serious and/or life-threatening reactions and to add ‘primidone’ and ‘Cystic fibrosis transmembrane conductance regulator potentiators: lumacaftor/ivacaftor’ under Medicinal products that are potent CYP3A inducers where significantly reduced nirmatrelvir/ritonavir plasma concentrations may be associated with the potential for loss of virologic response and possible resistance based on the review of the PI for a number of medicines from different drug classes that are metabolised by CYP3A4 or CYP2D6, transported by P-gp, or induce CYP3A4.
  • Update of section 4.5 of the SmPC in order to add drug-drug interaction information with Alpha1-adrenoreceptor antagonist, Analgesics, Antiarrhythmics, Anticoagulants, Anticonvulsants, Anti-HIV, Anti-infectives, β2-agonist (long acting), Calcium channel antagonists, Cardiovascular agents and Migraine medicinal products, to add drug-drug interaction information with Cystic fibrosis transmembrane conductance regulator potentiators, Dipeptidyl peptidase 4 (DPP4) inhibitors, Janus kinase (JAK) inhibitors, Mineralocorticoid receptor antagonists, Muscarinic receptor antagonists, Neuropsychiatric agents and Opioid antagonists and order to remove cross reference to section 4.4 from information regarding coadministration of Paxlovid with Antidepressants based on the review of the PI for a number of medicines from different drug classes that are metabolised by CYP3A4 or CYP2D6, transported by P-gp, or induce CYP3A4.”

Paxlovid - nirmatrelvir / ritonavir - Pfizer Europe MA EEIG,

• “Update of sections 4.8, 5.1 and 5.2 of the SmPC in order to update efficacy, safety and pharmacokinetic information, based on updated results from studies C4671005 (EPIC -HR), C4671002 (EPIC-SR) and C4671006 (EPIC-PEP) as well as a supplemental report to Pop PK analysis PMAR-EQDD-C467a-DP4-1323, following the reanalysis of data after the removal of data related to four sites from the Paxlovid data analysis.”

Document link: CHMP Minutes for the meeting on 24-26 April 2023