The European Medicines Agency (EMA) announced Wednesday that it is ending the evaluation of covid-19 treatment with monoclonal antibodies developed by U.S. drugmaker Eli Lilly after the company withdrew from the process.
The European regulator began a real-time analysis last March of the data becoming available on the antibodies used as a combination for the treatment of covid-19 in infected people but had not yet received enough data to confirm their safety, efficacy, and quality.
“At the time of the company’s recall, the EMA had received non-clinical (laboratory) data, clinical study data, data on the quality and manufacturing process of the antibodies, and the risk management plan (RMP),” the agency said today. Nevertheless, the EMA’s Committee for Medicinal Products for Human Use (CHMP) still had concerns about some quality issues for the treatment, which is intended for people over 12 years of age who do not require additional oxygen or are at increased risk of developing severe covid-19.
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The EMA stresses that the end of the drug’s evaluation is “a decision of the company,” which considered that it is not in a position to generate the additional data required by the CHMP for a “prospective concurrent validation “that would allow it to formally apply for a license for use in the European Union (EU). Therefore, Lilly anticipates that no new or additional drug manufacturing campaigns will be required in the foreseeable future.
Therefore, at this time, Lilly is not in a position to generate the additional data required by CHMP,” the company itself explained in a statement. The CHMP already provided a positive scientific opinion on using the monoclonal antibody combination to give a harmonized view in EU countries until it completes the assessments requested by the laboratories and an official European license is issued.
The EMA maintains that Lilly’s withdrawal from the process has no consequences on last March’s scientific opinion. Patients in the EU can continue to receive the drugs based on agreements made at national levels.
This is the second time in less than a month that this scenario has occurred. IN MID-OCTOBER, the EMA already put an end to the evaluation of data on the covid-19 vaccine developed by Germany’s CureVac, after the drugmaker abandoned the process to focus on another, a more advanced vaccine against the coronavirus.