Cape Town - The South African Health Products Regulatory Authority (Sahpra) has registered Paxlovid, an anti-viral oral medication effective to treat Covid-19 in adults that may be vulnerable.
Sahpra made the announcement on Monday, after the regulatory authority confirmed last month it received an application from pharmaceutical company Pfizer and that it was being reviewed.
Paxlovid, which contains Nirmatrelvir (150mg) and Ritonavir (100mg), is used for the treatment of mild to moderate Covid-19 in adults.
These are older patients who do not require supplemental oxygen and who are at increased risk for progression to severe Covid-19.
“Sahpra is committed to fast-tracking the registration of all health products that are of an urgent nature such as HIV-Aids, cancer, and Covid-19. As Covid-19 is a looming threat, the registration of Paxlovid heralds a welcome signal in the fight against this pandemic,” said chief executive officer, Dr Boitumelo Semete-Makokotlela.
Pfizer shared study results last year that Paxlovid was working well in reducing Covid-19-related hospitalisation or deaths.
“Final data from all high-risk patients enrolled in the confirmed prior results of interim analysis showing Paxlovid reduced risk of hospitalisation or death by 89% (within three days of symptom onset) and 88% (within five days of symptom onset) compared to placebo; no deaths compared to placebo in non-hospitalised, high-risk adults with Covid-19,” it said.
Paxlovid consists of tablets for a five-day oral treatment regimen, with morning and evening doses.
Expected side-effects include hypersensitivity reactions, diarrhoea, vomiting, and altered taste.
A shelf-life of 12 months is approved for Paxlovid when stored at or below 25 °C.
Cape Times