Pharmaceutical manufacturer MSD has confirmed it is to seek authorisation for its COVID-19 treatment molnupiravir from SA’s medicines regulator. If approved, the pill, molnupiravir, would be a potential game changer, as it would be the first treatment that at-risk patients could take at home, reports Business Day.
All the currently approved therapies used in SA – including dexamethasone and remdesivir – require intravenous administration, and are limited to a hospital setting.
As reported in MedicalBrief last week, Merck, as it is known in the US, and its partner, Ridgeback Biotherapeutics, have applied for emergency use authorisation for the pill from the US Food and Drug Administration, after interim analysis of a phase three trial of the drug found it halved the risk of hospitalisation and death in people at risk of developing severe COVID-19. The international trial included participants from SA and was so effective that clinicians halted enrolment early.
“Our regulatory teams across the world are preparing dossiers to submit to various regulatory bodies, including the SA Health Products Regulatory Authority,” said MSD’s MD for SA and Sub-Saharan Africa, Zweli Bashman. “We by no means believe it is a replacement for vaccines.”
BusinessDay pressreader article – Drugmaker seeks SA nod for COVID-19 pill (Open access)
See more from MedicalBrief archives:
Merck’s COVID antiviral pill may halve the risk of hospitalisation and death
Promising early findings from Merck/Ridgeback Phase 2a trial of oral COVID-19 therapeutic
Reduction in infectious SAR-CoV-2 with molnupiravir — Small US study