MORGANTOWN — Mylan’s Morgantown plant is restarting production of an anti-malaria medication that is under study as a potential treatment for the COVID-19 virus.
The drug is hydroxychloroquine sulfate; the tablets are approved by the U.S. Food and Drug Administration for the treatment of malaria, lupus erythematosus and rheumatoid arthritis.
President Trump on Thursday touted its cousin, chloroquine, as a potential treatment and mistakenly said it has been FDA approved for COVID-19.
Mylan clarified, “Although the product is not currently approved for use in the treatment of COVID-19, it is listed by the World Health Organization as a drug under investigation for efficacy against the coronavirus.”
The drug had been in short supply earlier in March, according to news reports, but Mylan and another generic drug firm, Israel-based Teva, are both ramping up production.
Mylan said in a press release, “The company continues to focus its efforts on protecting our employees, producing critically needed medications, and turning our scientific and operational expertise towards identifying additional ways we may be able to assist in the massive prevention, diagnosis and treatment efforts needed to counter the spread of COVID-19.”
The restart of hydroxychloroquine sulfate in Morgantown in order to meet potential increased demand is part of that effort, Mylan said. In the coming weeks, Mylan also plans to begin production outside the U.S.
“We look forward to working with governments and health authorities globally to ensure patient access to this medicine as and where needed,” Mylan said.
Mylan said it expects to be in a position to begin supplying the tablets by mid-April. “With the active pharmaceutical ingredient that we currently have available, will be able to ramp up manufacturing to provide 50 million tablets to potentially treat a total of more than 1.5 million patients. The potential use of this medicine for COVID-19 related treatment is pending additional FDA and other regulatory body guidance.”
Teva announced that it is donating more than 6 million doses of the tablets through wholesalers to hospitals across the U.S. “to meet the urgent demand for the medicine as an investigational target to treat COVID-19.”
Teva Executive Vice President, North America Commercial Brendan O’Grady said, “We are committed to helping to supply as many tablets as possible as demand for this treatment accelerates at no cost. Immediately upon learning of the potential benefit of hyroxychloroquine, Teva began to assess supply and to urgently acquire additional ingredients to make more product while arranging for all of what we had to be distributed immediately.”
Teva said it plans ship the 6 million tablets through wholesalers to hospitals by March 31, and more than 10 million within a month. It is reviewing supply of both hydroxychloroquine and chloroquine globally to determine whether there are additional supply and access opportunities for patients.
The Dominion Post asked Mylan if it planned to also donate tablets, and how the restarted production will affect the Morgantown plant; Mylan acknowledged the questions but was unable to supply the answers by deadline.
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