The EU Medicines Agency won’t decide on Merck’s COVID-19 pill before Christmas

Milan, December 17 (Reuters) – The EU drug regulatory agency won’t decide before Christmas whether Merck & Co (MRK.N) will approve the COVID-19 pill, a source familiar with the matter said as the region struggles is to their arsenal of drugs to combat the Omicron variant.

However, the European Medicines Agency (EMA) will decide before Christmas whether Gilead’s (GILD.O) will grant full marketing authorization for its intravenous antiviral drug remdesivir, the source said.

Should the Merck ruling on molnupiravir fall in the new year, it would be later than expected. In November, the agency announced that it would complete its review by the end of the year. Continue reading

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In response to requests for comments on the status of its reviews, the EMA announced on Thursday that it would publish the opinions adopted by its Medicinal Products Committee (CHMP) by Friday noon.

The EMA will hold its regular briefing with the media on December 21st.

In November, the EU regulatory authority issued guidelines to the member states on the use of the pill, even before the final EU-wide approval takes place. It has been recommended to be given within five days of the first symptoms to treat adults who do not need oxygen assistance and who are at risk of their disease getting worse. Continue reading

That was before the U.S. drugmaker released data suggesting the drug was significantly less effective than previously thought, reducing hospital stays and deaths by about 30% in its clinical trial of high-risk patients.

In addition to vaccines, home antiviral treatments are considered a critical weapon in fighting the virus almost two years after the pandemic began.

The decisions are made as the EU struggles to tame a surge in infections that threatens to overwhelm health systems and as the rapid spread of Omicron has led some governments to reimpose restrictions before the Christmas holidays. Continue reading

The EMA granted conditional marketing authorization for Remdesivir, which is marketed under the brand name Veklury, in July last year, and extended it for another year in May. Continue reading

Conditional approval allows drugs that meet an unmet medical need with less complete data than normally expected to be approved when the benefits of a drug’s immediate availability to patients outweigh the risks and requires at least an annual review. Continue reading

Standard approval would take five years.

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Reporting by Emilio Parodi in Milan Writing by Josephine Mason in London Editing by John Stonestreet and Mark Potter

Our standards: The Thomson Reuters Trust Principles.


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