Special Edition 2021

NEW PRODUCTS

EDITORS’ OPINION

Authorisation of remdesivir in the European Union: EMA needs to prioritise patients’ interests

Some of the reactions to the covid-19 pandemic have been irrational and harmful to society, particularly in the field of health care: reliable methods for evaluating drugs have been challenged; crackpot theories have been widely circu- lated; study results have been released prematurely with no quality control; poorly designed studies and trials abound, and so on. On 19 March 2020, the EMA rightly urged the scientific community to conduct randomised comparative trials, designed to generate robust evidence, when evaluating potential treatments for covid-19 (1). Yet on 25 June 2020, the EMA recommended the authorisation of remdesivir for certain covid-19 patients, despite the absence of robust evi- dence and many deficiencies in the data submitted by the pharmaceutical company: no detailed reports of the clinical trials; tenuous results; unknowns concerning the drug’s metabolism and potential interactions; incomplete toxicol­ ogy study results; etc. (2). Expedited analysis of drug evaluation data makes sense in a pandemic, so that a decision can be reached on its harm-benefit balance before all the usual data have been collated. But only if the preliminary clinical evaluation data available suggest that the drug is sufficiently effective to justify taking a certain amount of risk. This is certainly not the case for remdesivir .The data provided by the company point only to the need to continue its evaluation until its

harm-benefit balance is sufficiently clear (see “Remdesivir (Veklury°) and covid-19” p. 14). By granting marketing authorisation, the EMA might give some people the impression that it has fulfilled its role by expediting authorisation for a drug against a disease that is a major public health problem. But the reality is quite different. By accepting this unsound evaluation from Gilead, the company that markets remdesivir , and granting condi- tional marketing authorisation, EMA has hindered its evalu­ ation. Although it is conditional and will be reviewed in a year’s time, this authorisation removes the company’s main incentive to thoroughly evaluate the drug in comparative randomised trials, using clinically critical endpoints (inten- sive care procedures and mortality). Yet again, the EMA lacked rigour in its relationship with a pharmaceutical com- pany, and the price will be paid by patients and healthcare professionals, left in the dark over the harms and benefits of this treatment. ©Prescrire ▶ Translated from Rev Prescrire November 2020 Volume 40 N° 445 • Page 810 1- Prescrire Editorial Staff “Evidence required: for covid-19 too” Prescrire Int 2020; 29 (218): 199. 2- EMA - CHMP “Summary of opinion (initial authorisation) for Veklury” 25 June 2020: 1 page.

Prescrire Int • March 2021

COVID-19 UPDATE

Follow Prescrire’s independent, evidence-based analysis of the pandemic

Recent subjects include: • “Covid-19 vaccine Ad26.CoV2S (by Janssen): as with the other covid-19 vaccines, effective in the short term but unknowns remain” (23 March 2021) • “The AstraZeneca covid-19 vaccine: British epidemiological data on the vaccination of older adults, and reassuring pharmacovigilance data” (15 March 2021) • “Messenger RNA covid-19 vaccines: Prescrire’s in-depth analysis as of end February 2021” (2 March 2021)

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P rescrire I nternational S pecial E dition 2021 • P age 7