Bayer, Novartis, Teva donate chloroquine, hydroxychloroquine in hopes antimalarials are effective against COVID-19

Bayer, Novartis and Teva all announced donations of antimalarial drugs as part of global efforts exploring use of the medicines to treat patients with COVID-19 infection. Bayer will provide 3 million tablets of Resochin (chloroquine phosphate), while Novartis will donate up to 130 million doses of hydroxychloroquine by the end of May, with Teva initially supplying 6 million tablets of hydroxychloroquine sulphate by March 31, and more than 10 million within a month.

The donations come amid comments from US President Donald Trump suggesting that chloroquine will be made available by prescription "almost immediately" to treat patients with COVID-19 infection. Last month, officials in China suggested that chloroquine be included in the next version of the country's COVID-19 treatment guidelines as it "has a certain curative effect" on the coronavirus.

However, the American Society of Health-System Pharmacists (ASHP) recently added hydroxychloroquine to its list of medicines in short supply in the US, with four out of eight manufacturers of the drug currently reporting shortages. Erin Fox, senior director of drug information at University of Utah Health, who maintains ASHP's shortages list, said pharmacists are unable to get the drug or fill prescriptions in full.

According to Bayer, it has recently been in talks with the White House, US Department of Health and Human Services (HHS), US Centers for Disease Control and Prevention and the FDA regarding the supply of Resochin. Bayer noted that while Resochin is not approved in the US, the company is working on an emergency-use authorisation so that the drug can be used in the country.

Novartis said that its Sandoz division only holds a registration for hydroxychloroquine in the US, and will pursue appropriate regulatory authorisations from the FDA and European Medicines Agency. The Swiss drugmaker indicated that it is also exploring further scaling of capacity to increase supply.

Teva's hydroxychloroquine sulphate is currently approved by the FDA for the treatment of malaria, lupus erythematosus and rheumatoid arthritis. The Israeli company said that additional production of the drug is being assessed and subsequently ramped up, with Brendan O'Grady, executive vice president of Teva's commercial operations in North America, noting that the supply will be made "at no cost." Company spokeswoman Kelley Dougherty added "we're directly responding to a need that was brought to us by the US government…and the promise that is being seen in the use of this product for COVID-19."

Meanwhile, Mylan announced Thursday that it has restarted production of hydroxychloroquine sulphate tablets at its West Virginia manufacturing facility in the US and expects to be in a position to begin supplying product by mid-April, adding that with the active pharmaceutical ingredients it currently has on hand, it will be able to provide 50 million tablets to potentially treat more than 1.5 million patients. The company's drug is also currently approved by the FDA for malaria, lupus erythematosus and rheumatoid arthritis.

For related analysis, see KOL Views Results: Unfortunate silver lining of pandemic is finding a COVID-19 drug more likely, says leading expert, and ViewPoints: Initial glimmers of hope for COVID-19 therapeutics.

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