South Africans wishing to manage their COVID-19 symptoms, may now use Merck’s molnupiravir pill after the South African Health Products Regulatory Authority (SAHPRA) approved it yesterday. However, the National Department of Health, won’t be adding the pill to their available treatment options.
National Deportment of Health spokesperson, Foster Mohale, said that government was not planning to buy the treatment pill.
“We welcome the decision by SAHPRA to authorise the use of the pill in SA. However, we are not going to procure the pill for the public sector. The evaluation showed that it is not significantly better than how we treat COVID-19 now,” said Mohale.
It has since been reported that Dr Nicholas Crisp, acting Director-General of the National Health Department, said the pill is too costly.
Risk of hospitalisation, death slashed
SAHPRA’s green light comes after phase 2 and 3 clinical trials showed it reduces the risk of hospitalisation and death by 30% among at-risk people.
“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. Molnupiravir is only indicated for use in patients aged 18 years and older,” the regulatory authority said in a statement.
SAPHRA authorised with conditions the importation of a limited quantity of molnupiravir capsules for six months at first. It also warned that the pill is not recommended for pregnant women. Someone with COVID-19 would need to take 40 tablets (within 5 days after symptoms).
A welcome addition
Dr Boitumelo Semete-Makokotlela, SAPHRA CEO, welcomed the latest weapon to the COVID-19 arsenal.
“The authorisation of molnupiravir for compassionate use offers further therapy in the fight against COVID-19,” said Semete-Makokotlela.
She continued: “SAPHRA will continue to play its part in ensuring the quality, safety and efficacy of all health products, including innovative treatments, so the public is protected at all times.”
Hope for poorer nations
Currently, the United States government is paying about R10 500 for each course of molnupiravir. However, generic drugmakers will make cheap versions in a deal aimed at giving access to poorer nations.
The World Health Organisation (WHO) stated last October that the licensing agreement between the Medicines Patent Pool (MPP) and Merck was a step in the right direction.
“This will create broader access to the treatment by allowing generic licensees from around the world to prepare supplies and create more affordable versions of the medicine,” the statement read.
According to the US Food & Drug Administration (FDA), the most common side effects of molnupiravir are diarrhoea, nausea and dizziness – Health-e News