• Non ci sono risultati.

www.lilly.co.uk Eli Lilly and Company Limited 8 Arlington Square West Downshire Way Bracknell RG12 1PU England

N/A
N/A
Protected

Academic year: 2021

Condividi "www.lilly.co.uk Eli Lilly and Company Limited 8 Arlington Square West Downshire Way Bracknell RG12 1PU England"

Copied!
2
0
0

Testo completo

(1)

www.lilly.co.uk

Eli Lilly and Company Limited 8 Arlington Square West Downshire Way Bracknell RG12 1PU England

Eli Lilly European Regulatory Team

29 October 2021

Dr Enzmann, CHMP chair European Medicines Agency Domenico Scarlattilaan 6 1083 HS Amsterdam The Netherlands

Bamlanivimab(EMEA/H/C/005836/0000) and Etesevimab (EMEA/H/C/005837/0000)

Dear Dr Enzmann,

Subject: Withdrawal of rolling review for bamlanivimab (EMEA/H/C/005836/0000) and etesevimab (EMEA/H/C/005837/0000)

Eli Lilly Netherlands BV (Lilly) would like to inform you of the decision to no longer continue with the ongoing submissions and responses under rolling review for an eventual marketing authorisation

application for bamlanivimab and etesevimab for the treatment of confirmed COVID-19 in patients aged 12 years and older that do not require supplemental oxygen for COVID-19 and who are at increased risk of progressing to severe COVID-19.

The decision to no longer pursue a marketing authorisation application is based on the following reason:

CHMP has determined that prospective concurrent validation is required for submission of a formal marketing authorisation application. Given the current demand from EU member states, Lilly forecasts that no additional / new drug substance manufacturing campaigns will be needed for the foreseeable future. Therefore, at this point Lilly is not in a position to generate the additional data required by the CHMP to progress to a formal marketing authorization application.

Lilly would like to thank the Rapporteurs, EMA, and the scientific committees involved for the time dedicated to assessing the rolling review, and the valuable support and helpful guidance provided during this novel process.

(2)

Yours sincerely,

Senior Advisor-Global Regulatory Affairs - International

Riferimenti

Documenti correlati

The total area of this habitat has declined sevcrely and so has the traditional coppice management which maintains high quality understorey habitat for Muscurdinus

Nello studio di Fase III ANNOUNCE, i cui dati preliminari sono appena stati resi noti da Eli Lilly olaratumab, in combinazione con doxorubicina, in pazienti con sarcoma dei

Food and Drug Administration granted accelerated approval to olaratumab (LARTRUVO, Eli Lilly and Company) for the treatment of patients with soft tissue sarcoma (STS)

Che il farmaco - VERZENIOS 50 MG – 100 MG - 150 MG con principio attivo Abemaciclib, è commercializzato in esclusiva, sul territorio nazionale, dalla scrivente Eli Lilly

• Training load of each exercise was increased

13569 del 4 febbraio 2021, relativo ai medicinali prodotti delle aziende Eli Lilly e Regeneron/Roche con il quale si afferma che «pur considerando l'immaturita'

In aggiunta al valore creato dalla presenza e attività di Lilly in tutte le dimensioni sopra analizzate, le parole evidenziate nella figura seguente rappresentano una chiave

ricombinante ELI LILLY NEDERLAND BV 12:00 COPAXONE glatiramer acetato TEVA ITALIA S.R.L. 16:00 KEPIVANCE