Sahpra authorises oral Covid-19 medication, Molnupiravir

The South African Health Products Regulatory Authority (Saphra) has greenlighted the use of a new oral anti-viral medicine, Molnupiravir, against Covid-19.

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

Now, new oral antiviral medicines are becoming available to treat mild Covid-19 in adults who don’t need supplemental oxygen and who are at risk of progression to severe form of the virus.

One of these new medicines is Molnupiravir.

During the clinical trial, Molnupiravir was shown to reduce the risk of hospitalisation or death compared with placebo, but only when treatment was initiated within 5 days of the first symptoms of Covid-19.

Molnupiravir is only approved for patients aged 18 years and older.

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

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

Lagevrio will become available through the usual distribution chain, but it requires a prescription.

Lagevrio is not recommended during pregnancy because 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 adverse drug reactions are reported to Sahpra.

“MSD (Pty) Ltd has also submitted an application for the registration of “LAGEVRIO”, for which a rolling
review has commenced,” said Sahpra.

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

Pfizer has submitted an application for another oral antiviral for adults diagnosed with mild-to-moderate Covid-19, the co-packaged presentation of Nirmatrelvir and Ritonavir (“PAXLOVID”).

“The authorisation of Molnupiravir for compassionate use offers further therapy in the fight against Covid-19. Sahpra will continue to play its part 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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