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Gilead's (GILD) Remdesivir Gets CHMP Approval Recommendation

Zacks Equity Research

Gilead Sciences’ GILD experimental coronavirus candidate, Veklury (remdesivir), has been recommended for approval by the  European Medicines Agency (EMA)’s human medicines committee (CHMP).

The CHMP has recommended granting a conditional marketing authorization to Veklury for the treatment of COVID-19 in adults and adolescents from 12 years of age with pneumonia who require supplemental oxygen.

Remdesivir is the first medicine against COVID-19 to be recommended for authorization in the EU.

The committee reviewed the data in an exceptionally short timeframe through a rolling review procedure, which is generally used by the EMA during public health emergencies to assess data as they become available. This data primarily comprised data from the study NIAID-ACTT-1, sponsored by the U.S. National Institute of Allergy and Infectious Diseases (NIAID), along with supporting data from other studies on remdesivir.

This study evaluated the effectiveness of a planned 10-day course of remdesivir in more than 1,000 hospitalized COVID-19 patients compared with placebo and the main measure of effectiveness was patients’ time to recovery. The study showed that patients treated with remdesivir recovered after about 11 days compared with 15 days for patients given placebo.

Gilead’s shares have rallied 18.4% in the year so far compared with the industry’s growth of 13.6%. In fact, remdesivir is pioneering the race for a possible treatment of this deadly virus.

The FDA granted remdesivir an Emergency Use Authorization for the treatment of hospitalized patients with severe COVID-19, given the severity of the pandemic.

It was recently granted regulatory approval in Japan under an exceptional approval pathway.

While a potential approval of remdesivir will be a significant boost, there is uncertainty regarding the drug’s profitability in the long run.

Given the alarming levels of spread and severity, some approved drugs are being tested to see if they are effective in treating infected patients.

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 evaluating its rare disease drug, Ultomiris (ravulizumab-cwvz), for the COVID-19 infection.

Incyte INCY initiated RUXCOVID, a global, randomized, double-blind, placebo-controlled phase III study, evaluating the efficacy and safety of Jakafi plus SoC in patients 12 years and above with COVID-19-associated cytokine storm.

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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