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March 26, 2020

Mylan and Gilead waive exclusivity for potential Covid-19 therapies

Mylan has waived its exclusive rights to generic Kaletra (lopinavir/ritonavir) in the US to aid wider access in case the medication would be effective in treating Covid-19.

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Mylan has waived its exclusive rights to generic Kaletra (lopinavir / ritonavir) in the US to aid wider access in case the medication would be effective Covid-19 therapies.

The waiver will enable other generics to be eligible for the US Food and Drug Administration (FDA) approval for treating patients in the country, to expand availability when additional clinical trials or other evaluations demonstrate that the product could be an effective Covid-19 treatment.

Last week, Mylan announced the restart of manufacture of hydroxychloroquine sulfate tablets at its facility in the US to cater to demand that could result if the product is proven effective in treating Covid-19.

The company currently holds approval for hydroxychloroquine sulfate to treat malaria, lupus erythematosus and rheumatoid arthritis, now being evaluated to treat the novel coronavirus infection.

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Covid-19 therapies: Gilead rescinds remdesivir’s orphan drug designation

Gilead Sciences has requested the FDA to rescind the orphan drug designation awarded for the investigational antiviral drug remdesivir in Covid-19 indication.

The company is also waiving all benefits associated with the designation.

In a statement, Gilead said: “Gilead is confident that it can maintain an expedited timeline in seeking regulatory review of remdesivir, without the orphan drug designation.

“Recent engagement with regulatory agencies has demonstrated that submissions and review relating to remdesivir for the treatment of Covid-19 are being expedited.”

Remdesivir is among the existing drugs being broadly studied as potential Covid-19 treatments worldwide.

Meanwhile, Gilead temporarily halted emergency access to remdesivir due to rising demand.

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