By Emilio Parodi
MILAN (Reuters) – The EU drug regulator will not decide whether to approve Merck & Co’s COVID-19 pill until after Christmas, a source with knowledge of the matter said, as the region scrambles to boost its arsenal of drugs to fight the Omicron variant.
The European Medicines Agency (EMA) will, however, rule before Christmas on whether to give Gilead’s intravenous antiviral drug Remdesivir full marketing approval, the source said.
If the Merck ruling on molnupiravir comes in the new year, that would be later than expected. In November, the agency said it expected to complete its review by the year-end.
Responding to requests for comment on the status of its reviews, the EMA said on Thursday it would publish the opinions adopted by its human medicines committee (CHMP) by Friday midday.
The EMA is due to hold its regular briefing with media on Dec. 21.
In November, the EU regulator issued guidance to member states on using the pill even before final EU-wide approval. It advised it should be given within five days of first symptoms to treat adults who do not need oxygen support and are at risk of their disease worsening.
That was before the U.S. drugmaker released data suggesting the drug was significantly less effective than previously thought, reducing hospitalisations and deaths in its clinical trial of high-risk individuals by around 30%.
(Reporting by Emilio Parodi in Milan; Writing by Josephine Mason in London; Editing by John Stonestreet and Mark Potter)
