Novartis halts hydroxychloroquine trial after FDA yanks approval

A Swiss pharmaceutical company has stopped a clinical trial for hydroxychloroquine — a decision that comes days after the FDA yanked its emergency approval to use the drug to treat coronavirus.

The company cited a lack of participants and an inability to “collect meaningful data in a reasonable timeframe” in the cancellation announcement.

“Novartis has made the decision to stop and discontinue its sponsored HCQ clinical trial for COVID-19 due to acute enrollment challenges that have made trial completion infeasible,” the company said in a statement late Friday.

The drug, which is typically used to treat malaria, was previously hailed as a possible miracle medication for COVID-19 patients by President Trump, who said he was taking hydroxychloroquine himself to prevent the disease.

In recent weeks, agencies including the FDA and World Health Organization, have begun actively encouraging people not to take the drug.

The FDA on Monday cited a lack of evidence of its effectiveness and serious side effects when it canceled emergency-use authorization.

Novartis said “no safety issues have been reported, and there are no conclusions on efficacy from the study.”

The company sought to test 440 participants, but only managed to recruit a handful.

With Post wires


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