Regulator authorises Covid-19 pill for South Africa
The South African Health Products Regulatory Authority (Sahpra) has authorised access to Molnupiravir in the country.
“Until recently, the treatment options for patients with mild-to-moderate Covid-19 have been limited,” the regulator said in a statement on Thursday (17 February).
“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.”
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.
“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. This authorisation is for a limited quantity of Lagevrio and is initially limited to a period of six months.
“Imported Lagevrio 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.
Sahpra has welcomed the use of the molnupiravir pill as it can potentially lower your chances of South Africans falling seriously ill or dying from Covid.
“The authorisation of molnupiravir for compassionate use offers further therapy in the fight against Covid-19,” said Sahpra chief executive Dr Boitumelo Semete-Makokotlela.
“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.”
Media release: SAHPRA has authorised access to molnupiravir [thread]
Read full media release: https://t.co/dvD5o5HSag
— SAHPRA (@SAHPRA1) February 17, 2022
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