PITTSBURGH – Mylan Pharmaceuticals has announced that it is donating medications that may be effective against COVID-19 to U.S. and international groups that are conducting studies on the drugs.
As previously announced in March, Mylan re-started production of generic hydroxychloroquine sulfate tablets, 200mg, at its Morgantown, WV manufacturing site to meet increasing demand in the context of COVID-19. Mylan is donating 10 million tablets of hydroxychloroquine sulfate to the U.S. Department of Health and Human Services (HHS), for possible use under an investigational new drug application authorized by the U.S. Food and Drug Administration (FDA), according to a news release from the company. The FDA issued an Emergency Use Authorization permitting the emergency use of hydroxychloroquine sulfate supplied from the Strategic National Stockpile to treat adults and adolescents who weigh 110 lbs. or more and are hospitalized with COVID-19, company officials said.
The company has also begun shipping additional product to wholesalers in the U.S. to help support existing patient needs for hydroxychloroquine sulfate tablets traditional uses, which include the treatment of malaria, lupus erythematosus and rheumatoid arthritis, according to the news release.
Mylan is also donating medications to the World Health Organization (WHO) to support its investigation of the potential effectiveness of several medicines in treating COVID-19, it said. 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 WHO SOLIDARITIY trial is a multi-arm, multi-country, 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, Mylan officials said.
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. These therapies were chosen after an assessment of evidence by an independent WHO group of experts. On this basis they were prioritized for inclusion in the SOLIDARITY trial for evaluation of their effectiveness against the SARS-CoV 2 virus, which causes COVID-19, according to Mylan’s release.