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Covid drug gets interim approval as regulator continues testing

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Covid drug gets interim approval as regulator continues testing

SAHPRA is allowing emergency use of molnupiravir and has started a rolling review of the product

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The drug is for use in adults only and will be available on prescription to patients with mild to moderate Covid-19 who do not require supplemental oxygen, but are at risk of their disease becoming severe.
ADULTS ONLY The drug is for use in adults only and will be available on prescription to patients with mild to moderate Covid-19 who do not require supplemental oxygen, but are at risk of their disease becoming severe.
Image: Merck

The medicine regulator has given the go-ahead for emergency use of Merck’s Covid-19 drug, molnupiravir.

The SA arm of the US pharmaceutical giant has been given permission to import a limited quantity of 200mg capsules of the oral antiviral for six months for “compassionate use”, the SA Health Products Regulatory Authority (Sahpra) said on Thursday.

The medication, under the brand name Lagevrio, is for use in adults only and will be available on prescription to patients with mild to moderate Covid-19 who do not require supplemental oxygen but are at risk of their disease becoming severe.

In a clinical trial, Sahpra said in a statement, molnupiravir was found to reduce the risk of hospitalisation or death compared with a placebo, but only when treatment was initiated within five days of the first Covid-19 symptoms.

“Imported Lagevrio will be distributed through the usual distribution chain and will require prescription by an authorised prescriber, in accordance with the control measures applied to Schedule 4 substances,” it said.

“As studies in animals have shown reproductive toxicity, Lagevrio is not recommended during pregnancy. Women of childbearing potential should use effective contraception for the duration of treatment and for four days after the last dose of Lagevrio.”

Sahpra is considering an application from Pfizer for registration of its oral Covid-19 antiviral Paxlovid.
Sahpra is considering an application from Pfizer for registration of its oral Covid-19 antiviral Paxlovid.
Image: Pfizer

The regulator instructed Merck to ensure any adverse drug reactions associated with the use of Lagevrio are reported.

Sahpra said it had begun a rolling review of Lagevrio after Merck submitted an application for its registration and is considering applications for the use of generic products containing molnupiravir.

“An application for another oral antiviral for adults diagnosed with mild to moderate Covid-19, the co-packaged presentation of nirmatrelvir and ritonavir (Paxlovid), has been submitted by Pfizer (Pty) Ltd and is under consideration,” it said.

“The authorisation of molnupiravir for compassionate use offers further therapy in the fight against Covid-19.”

Sahpra CEO Boitumelo Semete-Makokotlela said the regulator would “continue to play its part in ensuring the quality, safety and efficacy of all health products, including innovative treatments, so the public is protected at all times”.

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