CAPE TOWN – The South African Health Products Regulatory Authority (Sahpra) has authorised access to a new oral antiviral medicine for Covid-19, called molnupiravir.
Making the announcement on Thursday, Sahpra said that until recently, the treatment options for patients with mild-to-moderate Covid-19 have been limited.
“New oral antiviral medicines are becoming available for the treatment of confirmed Covid-19 in adults who do not require supplemental oxygen, and who are at risk of progression to severe Covid-19. One of these new medicines is molnupiravir, Sahpra said.
“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.
The regulatory body has authorised, with conditions the importation of molnupiravir 200mg capsules called Lagevrio to be provided by biopharmaceutical company MSD, known as Merck in the US and Canada, in terms of section 21 of the Medicines and Related Substances Act, 1965.
This authorisation is for a limited quantity of Lagevrio and is initially limited to a period of six months. Imported Lagevrio will require prescription by an authorised prescriber, in accordance with the control measures applied to Schedule 4 substances.
“As studies in animals have shown reproductive toxicity, Lagevrio is not recommended during pregnancy. Women of childbearing potential should use effective contraception for the duration of treatment and for four days after the last dose of Lagevrio. MSD will ensure that any adverse drug reactions associated with the use of molnupiravir are reported to Sahpra,” it said.
MSD has also submitted an application for the registration of Lagevrio, for which a rolling review has commenced.
Sahpra said it 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 in Paxlovid, has been submitted by Pfizer and is under consideration at present.
Sahpra chief executive 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.”
Cape Times