Covid, Ema: stop reviewing Lilly monoclonals after company retirement

The European Medicines Agency Ema stops the rolling review procedure on the monoclonal antibodies bamlanivimab and etesevimab developed by Eli Lilly for the treatment of Covid-19, after the company informed Ema that it was withdrawing from the process. This was announced by the EU regulatory body in a note, specifying that in any case “patients can continue to receive drugs according to national provisions”. Since last March – Ema recalls in a note – the Committee for Medicinal Products for Human Use (CHMP) has been examining data on bamlanivimab and etesevimab as part of the cyclical review, a procedure whereby the company provides information by hand as they become available, so as to speed up the evaluation of a possible request for marketing authorization (Aic). Also in March, the Agency issued an opinion supported by the results of a clinical study, an opinion in which it supported the use of the two monoclonals against Covid at the level of the various states even before the Aic. – it continues – the EMA had received non-clinical (laboratory) data, data from clinical studies, data on the quality and production process of drugs, as well as the Risk Management Plan (Rmp). Despite the accelerated review of the data, according to the Agency “some issues concerning the quality of medicines remained to be addressed satisfactorily”. The company has decided to withdraw, motivated by reasons set out in a letter, and as a consequence “the EMA will stop analyzing the data and will not complete the review. Lilly reserves the right to request another rolling review or to submit an Aic application in the future “. In the letter from Eli Lilly Netherlands BV, of which the EU regulatory body disseminates the text, the company acknowledges the additional requests from the CHMP and writes as follows:” Given the current application from EU member states, Lilly predicts that no further / new drug production campaigns will be needed for the foreseeable future. Therefore, at this point Lilly is unable to generate the additional data required by the CHMP to switch to formal request from Aic “.