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Industry to boost supply of chloroquine, hydroxychloroquine despite limited data in COVID-19

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Novartis and Teva join a growing list of pharmas with plans to ramp up supply of antimalarial drug hydroxychloroquine in the U.S. for COVID-19 despite sparse clinical data supporting the drug's efficacy in the indication.

Chloroquine and its more tolerable derivative, hydroxychloroquine, have gained attention in light of President Donald Trump's statements during a March 19 press briefing, in which he called for widespread use of unapproved drugs under compassionate use and expressed great optimism for the antimalarials as treatment for COVID-19 (see "FDA Urged to Follow Science").

On Friday, Novartis AG (NYSE:NVS; SIX:NOVN) announced plans to donate up to 130 million 200 mg doses of hydroxychloroquine by the end of May to treat COVID-19. Teva Pharmaceutical Industries Ltd. (NYSE:TEVA; Tel Aviv:TEVA) similarly said late Thursday it would donate 6 million hydroxychloroquine sulfate tablets to U.S. hospitals by the end of March, and over 10 million within a month. Both companies are assessing ways to increase production.

Teva's announcement came just hours after Mylan N.V. (NASDAQ:MYL) revealed it had ramped up production of hydroxychloroquine sulfate tablets and Bayer AG (Xetra:BAYN) said it would donate 3 million tablets of Resochin chloroquine phosphate to the U.S. government.

But, while chloroquine and hydroxychloroquine have both been shown to block SARS-CoV-2 replication in cell culture, so far data in COVID-19 patients are scant, and data from randomized controlled clinical studies of the drugs have yet to emerge.

In mid-February, China's Ministry of Science and Technology (MOST) announced chloroquine had "fairly good efficacy" in COVID-19 patients, and reported that patients receiving the drug exhibited fever reduction and pulmonary improvement. However, detailed data haven't been disclosed (see "COVID-19 Update: Clinical Data Emerge").

Data from an open-label, non-randomized trial of hydroxychloroquine in COVID-19 patients in France were reported March 17. In the 36-patient study led by researchers at Aix-Marseille University, administration of hydroxychloroquine plus or minus the antibiotic azithromycin four days after symptom onset led to significant increases in the percentage of patients who had undetectable virus 3-6 days after treatment vs. those who did not receive the drug.

On day 6, 57.1% of patients receiving hydroxychloroquine alone saw viral clearance, versus 100% of patients on hydroxychloroquine plus azithromycin and 12.5% of patients who didn't receive the antimalarial (p<0.001).

According to ClinicalTrials.gov, at least 10 open-label or blinded randomized studies of chloroquine or hydroxychloroquine for COVID-19 have been initiated.

Further analysis of the coronavirus crisis can be found at https://www.biocentury.com/coronavirus.

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