(Reuters) – The European Medicines Agency (EMA) on Friday recommended extending conditional marketing approval by a year for Gilead Sciences’ COVID-19 treatment, remdesivir, the only drug so far that has been authorized for use in the region.
The regulator said its human medicines committee (CHMP) found that benefits of the drug outweighed risks, although the company was required to submit more data by the end of the year for the next scheduled renewal.
Remdesivir, sold under the brand name Veklury, was conditionally authorized in July last year for treating COVID-19 in adults and adolescents over 12 years with pneumonia requiring oxygen support.
In December, the regulator recommended changing some terms of the conditional approval after doubts over remdesivir’s effectiveness were raised following a World Health Organization (WHO) panel’s findings that there was no evidence the drug improved survival or reduced the need for ventilation.
Gilead last month posted 16% jump in first-quarter revenue to $6.4 billion, with remdesivir sales contributing $1.46 billion. It, however, said those sales would continue to be subject of significant volatility and uncertainty.
The conditional authorization allows approval of medicines that fulfill an unmet medical need with less complete data than normally expected, if the benefit of a medicine’s immediate availability to patients outweighs any risks, and requires a re-assessment at least once a year.
(This story has been refiled to add dropped word “billion” in paragraph 5)
(Reporting by Vishwadha Chander in Bengaluru; Editing by Anil D’Silva)
