The CHMP (Committee for Medicinal Products for Human Use) has, for the first time concerning COVID-19 specific treatments, made a recommendation to the EMA (European Medicines Agency) to grant a conditional marketing authorization for remdesivir, an antiviral drug.

The EMA, as of 3 July, has authorized the commercialization of remdesivir for the treatment of COVID-19 in patients from 12 years of age with pneumonia who require supplemental oxygen. In Europe, a conditional marketing authorization allows for the commercialization of this drug with less comprehensive data than usually required, when exceptional circumstances determine that the benefits outweigh the risks.

Meanwhile, the USA is being widely criticized for hoarding the supply of this drug, by striking a deal with the pharmaceutical company Gilead Sciences. Gilead had already come under scrutiny after announcing pricing for remdesivir last week.

Several studies were considered leading up to this recommendation, including the preliminary results of the NIAID-ACTT-1 study, published in May. The stage one preliminary data indicates a statistically significant reduction in recovery time for patients requiring hospitalization from 15 days for the control group to 11 days for the remdesivir group. Researchers highlight the benefits of starting antiviral treatment before mechanical ventilation is required due to pulmonary progression of the disease. Despite outcome improvements, mortality remained high, suggesting the exclusive use of an antiviral drug is insufficient in overcoming this disease.

Remdesivir continues to be studied in various trials, including WHO’s Solidarity trial, and France's DisCoVery trial.

The University of Oxford’s RECOVERY trial has found no clinical benefit in the use of hydroxychloroquine or lopinavir-ritonavir, but has provided valuable information concerning the use of dexamethasone in decreasing mortality in patients requiring oxygen therapy.

While many trials involving hydroxychloroquine and/or lopinavir-ritonavir, like RECOVERY, have been suspended or terminated, many other drugs continue to be researched and tested all over the world, including: immunomodulators (infliximab, tocilizumab, sarilumab, baricitinib, anakinra), corticosteroids (dexamethasone, prednisone, methylprednisolone), antivirals (favipiravir) and non-steroidal anti-inflammatory drugs (ibuprofen).

Advances continue to be made every day towards an effective and safe treatment of COVID-19, however, we are still a long way from a definitive treatment guideline.

Melanie Salgado

Pharmacist and Medication Content Analyst

ALERT Life Sciences Computing