The South African Health Products Regulatory Authority (SAHPRA) has given emergency authorisation to import an oral capsule, molnupiravir, said to be effective in treating
Clinical trials showed that the capsule reduced the risk of hospitalisation or death, but only when treatment was initiated within five days of the first symptoms of the virus.
SAHPRA said, however, that the capsule is not the replacement for vaccines.
Indicated for patients aged 18 years and older, the health products regulatory authority said it has authorised, with conditions, the import of molnupiravir 200mg capsules (LAGEVRIO), adding that the authorisation was for a limited quantity and is limited to six months.
SAHPRA added that the capsule will be distributed through the usual distribution chain, and will require a prescription by an authorised prescriber in accordance with the control measures applied to Schedule 4 substances.
SAHPRA said: “LAGEVRIO is not recommended during pregnancy. Women of child-bearing potential should use effective contraception for the duration of treatment and for four days after the last dose of LAGEVRIO.
“MSD (Pty) Ltd shall ensure that any adverse drug reactions associated with the use of molnupiravir [LAGEVRIO] are reported to SAHPRA. MSD (Pty) Ltd has also submitted an application for the registration of LAGEVRIO, for which a rolling review has commenced.”
SAHPRA is also reviewing 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 and is under consideration.
SAHPRA CEO Dr Boitumelo Semete-Makokotlela said: “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.”
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