EMA Expert Group Recommends Dexamethasone for COVID-19

The corticosteroid dexamethasone has earned the blessing of the EMA’s Committee for Medicinal Products for Human Use (CHMP) for treating COVID-19 patients who require oxygen therapy.

The recommendation was based on the results of the UK’s Recovery trial, which found that the corticosteroid reduced deaths by one-third in ventilated patients and by one-fifth in patients only receiving oxygen.

The results showed 29 percent of mechanically ventilated patients given dexamethasone died within 28 days of starting treatment compared to 41 percent of patients receiving usual care, with a relative reduction of about 35 percent. For patients receiving oxygen without mechanical ventilation, 23 percent died in the dexamethasone group compared to 26 percent in usual care, a relative reduction of about 20 percent.

The EMA has already backed the advisory group’s decision, announcing that it endorses dexamethasone’s use in adults and adolescents aged 12 and older who require oxygen therapy. The agency said the drug can be taken orally or given via injection or infusion, and it recommended a dose of 6 mg daily for up to 10 days in all cases.

“Companies that market dexamethasone medicines can request this new use to be added to their product’s license by submitting an application to national medicines agencies or to EMA,” the agency said.

Dexamethasone, a cheap and common corticosteroid that has received approval in Japan as a COVID-19 treatment, is likely to see a surge in demand with this development, given that hospitals clamored for the drug after the University of Oxford announced positive trial results in June (DID, June 26).

The expert committee also recommended seven other drugs for approval at its monthly meeting. It adopted positive opinions for Pacira’s Exparel (bupivacaine) and Pfizer’s pegfilgrastim biosimilar, Nyvepria, recommending the Pacira drug for treating postoperative pain and the biosimilar for reducing the duration of neutropenia and the incidence of febrile neutropenia after chemotherapy.

In addition, it recommended marketing authorizations for two Sanofi vaccines, the quadrivalent meningococcal vaccine MenQuadfi and the quadrivalent influenza vaccine Supemtek.

A marketing authorization was also suggested for Adienne’s Phelinun (melphalan) for treating certain forms of cancer, including hematological cancer, and as a reduced intensity conditioning treatment before allogeneic hematopoietic stem-cell transplants. Additionally, Accord Healthcare’s generic rivaroxaban was recommended for treating and preventing venous thromboembolism, pulmonary embolism and the prevention of atherothrombotic events in at-risk adults.

In addition, SFL Regulatory Services’ generic obiltoxaximab was recommended for treating and postexposure prophylaxis of inhalational anthrax “under exceptional circumstances.” — James Miessler