Medicines regulators around the world have pledged to support the rapid approval of medicines to treat COVID-19, where there is adequate evidence of safety and therapeutic benefit.
The UK Government has fast-tracked authorisation of the use of well-known corticosteroid, dexamethasone, for the treatment of hospitalised COVID-19 patients requiring oxygen, including those who are on ventilators. This follows the successful RECOVERY trial involving over 6,000 patients randomised to dexamethasone treatment and standard care without the drug. The trial found a 20% risk reduction of mortality for those on oxygen and 35% risk reduction of mortality for ventilated patients.
The government has also added dexamethasone to the parallel export list. This excludes the listed medicines from UK purchase for resale abroad, in order to prevent depletion of UK supplies. Hoarding or exporting a listed medicine amounts to a breach of the Human Medicines Regulations 2012, and a contravention of the wholesale dealer licence.
This article was written by Medilink East Midlands Patron, Mills and Reeve.