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Roche's Tocilizumab, Gilead's Remdesivir Combo Fails To Improve Hospital Discharge Time in COVID-19 Study


Roche Holdings AG (OTCQX: RHHBY) has announced data from Phase 3 REMDACTA trial evaluating Actemra/RoActemra (tocilizumab) plus Gilead Sciences Inc's (NASDAQ: GILD) Veklury (remdesivir).

  • The study did not meet the primary endpoint of improved time to hospital discharge up to day 28 in patients for Actemra + Veklury versus placebo plus Veklury.
  • No new safety signals were identified in the REMDACTA trial.
  • Roche will continue to evaluate data from REMDACTA, COVACTA, and EMPACTA studies, as well as other studies of Actemra/RoActemra in COVID-19 pneumonia.
  • The EMPACTA study met its primary endpoint, while the COVACTA study did not meet its primary endpoint. Both were recently published in the New England Journal of Medicine.
  • REMDACTA's study failed to meet the key secondary endpoints, including the likelihood of death, the possibility of progression to mechanical ventilation or death, and clinical status.
  • Complete results of the trial will be submitted for publication in a peer-reviewed journal later this year.
  • Last month, data from the Recovery trial found that Actemra, when combined with steroid dexamethasone, reduced death rates by around 33% among the most severely ill COVID-19 patients.
  • Recently, the FDA approved Actemra for injection for slowing the rate of decline in pulmonary function in adult patients with systemic sclerosis-associated interstitial lung disease.
  • Price Action: RHHBY shares closed 2% up at $41.95 on Wednesday.

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Posted-In: Covid-19 Phase 3Biotech News Health Care FDA General

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