The South African Health Products Regulatory Authority (Sahpra) has authorised the use of molnupiravir in the country for the treatment of Covid-19 positive adults who do not require oxygen but who are at risk of progression to severe Covid-19.

The molnupiravir 200 mg capsules, or LAGEVRIO, were authorised with conditions.

Sahpra CEO Dr Boitumelo Semete-Makokotlela pointed out that this authorisation is for a limited quantity of “Lagevrio” and is initially limited to six months.

“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,” she said.

In a 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 and will require a prescription.

The treatment is not recommended for pregnant women and Semete-Makokotlela further stressed that women of childbearing potential should use contraception for the duration of treatment and for 4 days after the last dose.

The Regulatory Authority is also reviewing applications for the use of generic products containing molnupiravir.

Sahpra is also considering Pfizer’s application for the co-packaged presentation of nirmatrelvir and ritonavir “paxlovid”.