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



By Emilio Parodi

MILAN, Dec 17 (Reuters) - The EU drug regulator will not decide whether to approve Merck & Co's MRK.N 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.

But the European Medicines Agency (EMA) will rule before Christmas on whether to give Gilead's GILD.O 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 by the year-end its review of the pill developed by Merck with Ridgeback Biotherapeutics.

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 2020 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.



EXPLAINER-How worried should we be about the Omicron variant?

FACTBOX-Countries rush to buy experimental antiviral COVID-19
pills



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

Disclaimer: The XM Group entities provide execution-only service and access to our Online Trading Facility, permitting a person to view and/or use the content available on or via the website, is not intended to change or expand on this, nor does it change or expand on this. Such access and use are always subject to: (i) Terms and Conditions; (ii) Risk Warnings; and (iii) Full Disclaimer. Such content is therefore provided as no more than general information. Particularly, please be aware that the contents of our Online Trading Facility are neither a solicitation, nor an offer to enter any transactions on the financial markets. Trading on any financial market involves a significant level of risk to your capital.

All material published on our Online Trading Facility is intended for educational/informational purposes only, and does not contain – nor should it be considered as containing – financial, investment tax or trading advice and recommendations; or a record of our trading prices; or an offer of, or solicitation for, a transaction in any financial instruments; or unsolicited financial promotions to you.

Any third-party content, as well as content prepared by XM, such as: opinions, news, research, analyses, prices and other information or links to third-party sites contained on this website are provided on an “as-is” basis, as general market commentary, and do not constitute investment advice. To the extent that any content is construed as investment research, you must note and accept that the content was not intended to and has not been prepared in accordance with legal requirements designed to promote the independence of investment research and as such, it would be considered as marketing communication under the relevant laws and regulations. Please ensure that you have read and understood our Notification on Non-Independent Investment. Research and Risk Warning concerning the foregoing information, which can be accessed here.

We are using cookies to give you the best experience on our website. Read more or change your cookie settings.

Risk Warning: Your capital is at risk. Leveraged products may not be suitable for everyone. Please consider our Risk Disclosure.