Novartis Joins Effort to Vet Malaria Drug Hydroxychloroquine for Coronavirus
Novartis Joins Effort to Vet Malaria Drug Hydroxychloroquine for Coronavirus
(Bloomberg) --
Novartis AG will run a U.S. study of the malaria drug hydroxychloroquine for Covid-19, the latest effort to determine whether the hyped medicine can help in the battle against the pandemic.
The 65-year-old medicine will be tested against a placebo alone and in combination with the antibiotic azithromycin in a study of about 440 hospitalized patients, the Swiss drugmaker said Monday. Novartis hopes to have results as soon as early summer.
With no drugs proven to defeat the new coronavirus, doctors are using medicines developed for other ailments and reporting some successes that then need to be verified or debunked in clinical trials.
“We really need to find out whether hydroxychloroquine is an effective treatment for Covid-19 and answer the question in a scientifically rigorous way,” John Tsai, Novartis’s head of global drug development, said in an interview. “Otherwise this may go unanswered, or we’ll have results that point in different directions.”
Hydroxychloroquine, endorsed by President Donald Trump after showing promise in a small but unconventional study in France, is among the treatments that have sparked hope. Studies backed by the World Health Organization and the National Institutes of Health, as well as more than a dozen trials in China, are already investigating its effect.
That research could yield early results just as Novartis begins enlisting patients for its trial.
The Basel, Switzerland-based drugmaker is recruiting Covid-19 patients with moderate-to-severe illness for a study in which neither patients nor doctors know who’s receiving the drug -- a key to eliminating bias. Novartis will use what it believes to be the right doses for patients, according to Tsai. The company said it plans to test 200 milligram doses three times a day, after a dose of 600 milligrams on the first day of treatment.
“The faster we can recruit these patients, the faster we’ll get the results, so we’ll move very quickly in terms of getting feedback on this,” he said.
Demand is already soaring for the medicine, which is cheap and can be manufactured by many drugmakers. France’s Sanofi said this month that it would donate 100 million doses of hydroxychloroquine to 50 countries. Novartis pledged to donate up to 130 million tablets to supply global clinical research efforts and make the intellectual property available if the drug proves effective against Covid-19.
Some studies testing hydroxychloroquine have shown potential side effects, the most common being diarrhea, while there have also been reports of heart-rhythm problems and deaths.
Novartis said it may also test two of its newer prescription medicines against the coronavirus: the anti-inflammatory drug canakinumab and ruxolitinib, a treatment for bone marrow disorders.
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