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Mylan donating 10 million tablets of possible COVID-19 drug for FDA investigation

MORGANTOWN — Mylan announced on Wednesday that it is donating 10 million tablets of hydroxychloroquine sulfate, 200mg, to the U.S. Department of Health and Human Services for possible use as an investigational treatment for COVID-19.

Mylan would make this donation for possible use under an investigational new drug application authorized by the U.S. Food and Drug Administration or an Emergency Use Authorization granted by the FDA, it said.

The drug is FDA-approved to treat malaria, lupus erythematosus and rheumatoid arthritis.

In addition, Mylan said it is donating product to the World Health Organization to support its investigation of the potential effectiveness of several medicines in treating COVID-19. Mylan is the only company providing hydroxychloroquine sulfate tablets, 200mg, and one of three companies supplying lopinavir/ritonavir tablets, 200/50mg, as part of the WHO’s global SOLIDARITY trial.

The Dominion Post reported in March that Mylan re-started production of generic hydroxychloroquine sulfate tablets, at its Morgantown plant to meet increasing demand in the context of COVID-19. Mylan said Wednesday it has expedited its manufacturing of hydroxychloroquine tablets and product has been made available ahead of schedule.

Mylan explained that FDA issued an Emergency Use Authorization to permit the emergency use of hydroxychloroquine sulfate supplied from the Strategic National Stockpile to treat adults and adolescents who weigh 50 kilograms (about 110 pounds) or more and are hospitalized with COVID-19 for whom a clinical trial is not available, or participation is not feasible.

Mylan said it has also begun shipping additional product to wholesalers within the U.S. to help support existing patient needs to address shortages for FDA-approved product use.

WHO’s SOLIDARITIY trial, Mylan explained, is a multi-arm, multi-country, adaptive, clinical trial investigating potential therapies to treat COVID-19. It is part of the WHO’s accelerated effort to determine which, if any, of four therapies reduce mortality, hospital duration, and/or the need for ventilation or ICU for patients diagnosed as COVID-19 positive.

The therapies being investigated are the antiviral remdesivir; a combination of two HIV drugs, lopinavir and ritonavir; lopinavir/ritonavir plus interferon beta-1a; and hydroxychloroquine.

Mylan said these therapies were chosen after an assessment of evidence by an independent WHO group of experts. As new evidence emerges, WHO may decide to add novel treatment arms while the trial is in progress.

On the employee front, Mylan said that while business operations are considered essential based on government guidelines, many Mylan administrative offices are operating under work from home protocols. Mylan has also taken extra precautions at manufacturing facilities to aid in the protection of site personnel and operations, including the implementation of social distancing guidelines, daily health assessments and split shifts where feasible.

“These truly unprecedented times require everyone in the health care industry to work together to meet the challenges both at hand and ahead,” Mylan said. “Mylan pledges to continue to do its part to support employees, patients, partners and communities throughout this multi-stage journey.”

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