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SAHPRA Approves Oral Covid-19 Medications



The South African Health Products Regulatory Authority has given the green light to use a new oral antiviral drug, Molnupiravir, against Covid-19.

“Until recently, treatment options for patients with mild to moderate Covid-19 were limited,” said Boitumelo Semete-Makokotlela, CEO of Saphra.

Now, new oral antiviral drugs are becoming available to treat mild Covid-19 in adults who do not require supplemental oxygen and who are at risk of progression to a severe form of the virus.

One of these new drugs is Molnupiravir.

In the clinical trial, Molnupiravir was shown to reduce the risk of hospitalization or death compared to placebo, but only when treatment was started within 5 days of the onset of Covid-19 symptoms.

Molnupiravir is only approved for patients 18 years of age and older.

“Sahpra has, subject to conditions, authorized the importation of Molnupiravir 200 mg capsules (“Lagevrio”), to be supplied by MSD (Pty) Ltd, in terms of Section 21 of the Medicines and Related Substances Act, 1965,” said Semete -Makokotlela .

“This license is for a limited amount of Lagevrio and is initially limited to a period of six months.”

Lagevrio will be available through the usual distribution chain, but this requires a prescription.

Lagevrio is not recommended during pregnancy as animals showed signs of ‘toxic reproduction’ during testing.

Women of childbearing potential should use effective contraception for the duration of treatment and for four days after the last dose of Lagevrio.

MSD, the company that makes Lagevrio, says it will ensure that any drug side effects are reported to Sahpra.

“MSD (Pty) Ltd has also applied for the registration of “LAGEVRIO”, for which a rolling
review has begun,” said Sahpra.

It also reviews applications for the use of generic products containing Molnupiravir.

Pfizer has filed for another oral antiviral drug for adults diagnosed with mild to moderate Covid-19, the combined presentation of Nirmatrelvir and Ritonavir (“PAXLOVID”).

“The authorization of Molnupiravir for use in compassion provides further therapy in the fight against Covid-19. sahpra will continue to play its role in ensuring the quality, safety and efficacy of all health products, including innovative treatments, so that the public is protected at all times,” said Semete-Makokotlela.

compiled by Narissa Subramoney

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