The EMA’s Committee for Medicinal Products for Human Use (CHMP) yesterday recommended granting Gilead Sciences’ remdesivir a conditional marketing authorization as a COVID-19 treatment.
Under the committee’s rolling review process in place during the pandemic, the CHMP carried out a review of the antiviral’s trial in record time, starting on April 30. Gilead filed for the EMA’s authorization on June 5. The EMA generally follows the CHMP’s recommendations.
The committee’s recommendation was based on the results of the NIH’s National Institutes of Allergy and Infectious Diseases remdesivir trial, which showed patients recovered faster on the drug than those given a placebo (DID, April 30).
It is unclear what price Gilead will set for the drug. The Institute for Clinical and Economic Review (ICER) initially estimated that remdesivir would need to cost no more than $4,500 for a 10-day COVID-19 treatment to be cost-effective (DID, May 5).
But ICER has since adjusted its estimate to take the steroid dexamethasone, which has been heralded in recent days as an effective COVID treatment, into account. If dexamethasone is included in the standard-of-care, ICER now says remdesivir would need to cost between $2,580 and $2,800 to be cost-effective.
Read the ICER report here: www.fdanews.com/06-25-20-ICERCOVIDRevisedReport.pdf. — Jordan Williams