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Novartis Discontinues HCQ Study Due to Enrollment Challenges

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Novartis (NVS - Free Report) announced that it will discontinue the sponsored hydroxychloroquine (HCQ) study for COVID-19 due to acute enrollment challenges, which made trial completion infeasible.

As a result, the clinical team will not be able to collect meaningful data in a reasonable timeframe to determine the effectiveness of HCQ in treating COVID-19 patients.

However, Novartis will continue to supply HCQ for ongoing investigator-initiated trials.

Shares of the company have lost 2% in the year so far compared with the industry’s decline of 0.1%.

We note that the FDA recently revoked the emergency use authorization of HCQ for COVID-19 treatment. This decision was taken based on recent results from a large, randomized clinical study in hospitalized patients. The study showed that these medicines did not show any benefit for decreasing the likelihood of death or speeding recovery.

Moreover, there were reports of serious heart rhythm problems in patients with COVID-19 treated with hydroxychloroquine or chloroquine, often in combination with azithromycin and other QT-prolonging medicines.

Hydroxychloroquine and chloroquine are FDA-approved treatments to treat or prevent malaria. Hydroxychloroquine is also approved by the FDA to treat autoimmune conditions such as chronic discoid lupus erythematosus, systemic lupus erythematosus in adults and rheumatoid arthritis.

In March, the FDA allowed the use of these drugs for certain hospitalized patients for emergency uses. Thereafter, companies like Mylan (MYL - Free Report) and Teva (TEVA - Free Report) jumped the bandwagon and started producing HCQ tablets and donating the same.

We note that there are currently no FDA-approved treatments for the severe illness caused by SARS-CoV-2. Given the alarming levels of spread and severity, some approved drugs or pipeline candidates are being tested to see if they are effective in treating infected patients.

Among these, Gilead’s (GILD - Free Report) remdesivir is pioneering the race. The company earlier reported mixed results from a late-stage study on remdesivir in hospitalized patients with moderate COVID-19 pneumonia. Data showed that patients in the five-day remdesivir treatment group were 65% more likely to have clinical improvement at day 11 compared with those in the standard-of-care group. The odds of improvement in clinical status for the 10-day treatment course of remdesivir versus standard of care alone were also favorable but did not attain statistical significance.

It is a race against time for these pharma/biotech companies now to cure the infected and contain the spread of the contagion by developing a vaccine.

Novartis currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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