MORGANTOWN — Mylan’s Morgantown plan 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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