SA’s medicines regulator has authorised access to molnupiravir

Authorised access to this oral antiviral medicine brings about new treatment options in the COVID-19 fight.

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. “Until recently, the treatment options for patients with mild-to-moderate COVID-19 have been limited,” said SAHPRA in a statement released on Thursday. Molnupiravir is a medication that works by introducing errors into the SARS-CoV-2 virus’ genetic code, which prevents the virus from further replicating. “In a phase 2/3 clinical trial, molnupiravir was shown to reduce the risk of hospitalisation or death compared with placebo, but only when treatment was initiated within five days of the first symptoms of COVID-19. Molnupiravir is only indicated for use in patients aged 18 years and older,” the regulatory authority said.

This authorisation, however, is for a limited quantity of Lagevrio and is initially limited to a period of six months. The regulator added that, "imported Lagevrio will be distributed through the normal distribution chain and will require a prescription from an authorised prescriber in accordance with the Schedule 4 substance control regulations”. “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 SAHPRA CEO, Dr Boitumelo Semete-Makokotlela. MSD has also submitted an application for Lagevrio's registration, for which a rolling review has now commenced.