OR WAIT null SECS
EMA has ended rolling review of bamlanivimab and etesevimab COVID-19 antibody treatments after Eli Lilly Netherlands BV withdraws from the review process.
The European Medicines Agency announced on Nov. 2, 2021 that it was stopping its rolling review of bamlanivimab and etesevimab COVID-19 antibody treatments after Eli Lilly Netherlands BV decided to remove the treatments from the review process. EMA’s Committee for Medicinal Products for Human Use (CHMP) had been reviewing data on the two products as part of the rolling review since March 2021. According to EMA, there were questions about the quality of the treatments.
In a letter from Lilly to EMA, the company stated that “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.”
EMA stated in a press release that Lilly may request another rolling review or submit an application for market authorization in the future. “The withdrawal has no consequences on the previous advice issued in March and patients may continue to receive the medicines based on national arrangements,” the agency stated in the release.