Merck seeks FDA approval for COVID-19 drug

United States pharmaceutical big Merck mentioned on Monday that it has utilized for emergency use authorisation of its oral anti-COVID drug in the US, a significant step in direction of discovering a easy capsule to deal with the illness.

Merck has submitted the applying for molnupiravir, which it mentioned earlier this month was proven to cut back hospitalisations by 50 per cent.

It mentioned it was working “with regulatory businesses worldwide to submit functions for emergency use or advertising and marketing authorization within the coming months.”

“The extraordinary influence of this pandemic calls for that we transfer with unprecedented urgency,” Robert Davis, chief govt officer and president of Merck, mentioned within the assertion.

“That’s what our groups have completed by submitting this software for molnupiravir to the FDA inside 10 days of receiving the information,” he added. 

Wendy Holman, chief govt of Merck’s accomplice Ridgeback Biotherapeutics, referred to as the applying a “crucial step in direction of making molnupiravir accessible to individuals who might profit from an oral antiviral drugs that may be taken at residence shortly after analysis with COVID-19.”

In a late stage medical trial, Merck and Ridgeback evaluated information from round 770 sufferers – roughly half of whom acquired both a five-day course of the capsule, whereas the opposite acquired a placebo.

All of the sufferers had lab-confirmed COVID-19 with signs that developed inside 5 days of them being assigned to their respective teams.

Of the sufferers who acquired molnupiravir, 7.3 p.c have been hospitalised by day 29, in comparison with 14.1 per cent of these on a placebo – a relative danger discount of round 50 per cent. 

Efficacy was mentioned to carry up in opposition to variants of concern, together with Delta, and the drug had security profile.

Specialists have mentioned it isn’t a miracle remedy and will complement vaccines, not change them.

Merck mentioned within the assertion that it expects to provide 10 million programs of therapy by the top of 2021, with extra programs anticipated to be produced in 2022.

The US has procured 1.7 million programs of molnupiravir ought to or not it’s authorised, with the choice to purchase extra, and world well being company Unitaid mentioned it was working with a partnership referred to as ACT-Accelerator to safe provide for low- and middle-income nations.

Merck mentioned it “plans to implement a tiered pricing method primarily based on World Financial institution nation earnings standards to replicate nations’ relative skill to finance their well being response to the pandemic.”

The corporate mentioned that, pending authorizations, it has additionally signed non-exclusive voluntary licensing agreements for molnupiravir with established Indian generic producers to speed up the drug’s availability in additional than 100 low- and middle-income nations.



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Updated on January 14, 2022 5:18 am
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Updated on January 14, 2022 5:18 am

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