Gilead Sciences, Inc. GILD announced that the European Commission has granted conditional marketing authorization to Veklury (remdesivir) as a treatment for SARS-CoV-2 infection, the virus that causes COVID-19.
Veklury is indicated for the treatment of COVID-19 in adults and adolescents (aged 12 years and older and weighing at least 40 kg), with pneumonia requiring supplemental oxygen.
Given the alarming levels of the spread of the pandemic and the urgent need for a treatment, the conditional marketing authorization was granted based on a rolling review of supporting data that began in April 2020.
A conditional marketing authorization in Europe is initially valid for one year but can be extended to or converted into an unconditional marketing authorization after the submission and assessment of additional confirmatory data.
The authorization for Veklury is supported by the U.S. National Institute of Allergy and Infectious Diseases’ global phase III study of remdesivir.
Currently, there are no FDA-approved treatments for the severe illness caused by SARS-CoV-2. The pharma/biotech sector is running a race against time to come up with treatments and vaccines to cure the contagion.
The FDA also granted remdesivir an Emergency Use Authorization for the treatment of hospitalized patients with severe COVID-19, given the severity of the pandemic. It was granted regulatory approval in Japan under an exceptional approval pathway. The company recently announced the pricing of the drug. It set a price for governments of developed countries at $390 per vial, which equates to $2,340 per patient as the vast majority of patients are expected to receive a five-day treatment course using six vials of remdesivir.
Gilead’s shares have rallied 19.8% in the year so far compared with the industry’s growth of 11%. In fact, remdesivir is pioneering the race for a possible treatment of this deadly virus.
The drug is being evaluated in multiple ongoing international phase III studies for efficacy and safety.
Meanwhile, Roche RHHBY too initiated a late-stage study on its arthritis drug, Actemra/RoActemra, in combination with remdesivir in hospitalized patients with severe COVID-19 pneumonia. Alexion ALXN is also evaluating its rare disease drug, Ultomiris (ravulizumab-cwvz), for the COVID-19 infection.
However, the task is quite daunting. Regeneron Pharmaceuticals, Inc. REGN and partner Sanofi announced that the phase III study evaluating their IL-6 inhibitor, Kevzara (sarilumab), in hospitalized patients with severe COVID-19 failed to meet its primary endpoint. The drug also showed negative trends in a subgroup of critical patients who were not mechanically ventilated at baseline. The study has been stopped following the recommendation of an Independent Data Monitoring Committee (“IDMC”) based on these results.
Separately, Gilead announced data from an ongoing phase I study, which showed that a sustained-delivery subcutaneous formulation of its investigational, novel inhibitor of HIV-1 capsid function, lenacapavir (GS-6207), sustained predicted therapeutic concentrations for at least six months following a single 900 mg dose. In the study, lenacapavir was generally well-tolerated, and no serious adverse events were reported.
The company currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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Click to get this free report Alexion Pharmaceuticals, Inc. (ALXN) : Free Stock Analysis Report Regeneron Pharmaceuticals, Inc. (REGN) : Free Stock Analysis Report Roche Holding AG (RHHBY) : Free Stock Analysis Report Gilead Sciences, Inc. (GILD) : Free Stock Analysis Report To read this article on Zacks.com click here.