EU drug regulator won't rule on Merck COVID-19 pill before Christmas - source

[December 17, 2021]  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%.

Alongside vaccines, the at-home antiviral treatments are considered a critical weapon for fighting the virus nearly two years into the pandemic.

The decisions come as the EU struggles to tame a spike in infections, which threatens to overwhelm healthcare systems and as Omicron's rapid spread has prompted some governments to reimpose restrictions ahead of the Christmas holidays.

The EMA gave conditional marketing approval for Remdesivir, sold under the brand name Veklury, in July last year and extended that for another year in May.

Conditional authorisation allows approval of medicines that fulfil 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 review at least once a year.

Standard approval would last five years.

(Reporting by Emilio Parodi in MilanWriting by Josephine Mason in LondonEditing by John Stonestreet and Mark Potter)

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