Gilead notches remdesivir indication to treat young children

FDA has announced that it has signed off on the use of COVID-19 therapy Veklury (remdesivir) from Gilead Sciences (Nasdaq:GILD) to include children at least 28 days old who weigh at least 3 kg (roughly 7 lb) and test positive results for COVID-19.

The indication is limited to children who are either hospitalized or have a high risk of developing severe COVID-19, including hospitalization or death.

In October 2020, remdesivir became the first FDA-approved COVID-19 treatment and is now the first drug to win approval for children under 12 years of age.

Remdesivir was formerly authorized for use in young children under emergency use authorization but was FDA-approved for COVID-19-infected individuals at least 12 years old who weigh at least 40 kg (roughly 88 lb).

“As COVID-19 can cause severe illness in children, some of whom do not currently have a vaccination option, there continues to be a need for safe and effective COVID-19 treatment options for …

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FDA authorizes Pfizer’s Paxlovid oral COVID-19 antiviral

Pfizer’s (NYSE:PFE) Paxlovid (nirmatrelvir tablets and ritonavir tablets, co-packaged for oral use) became the first oral SARS-CoV-2 antiviral to win emergency use authorization (EUA).

The EUA covers the use of the drug to treat mild-to-moderate COVID-19 in patients who are at least 12 and weighing at least 40 kg (88 pounds).

The agency has yet to officially weigh in on molnupiravir, an oral antiviral from Merck and Ridgeback Biotherapeutics that has won approval in the U.K. In late November, an FDA advisory committee narrowly blacked that drug.

FDA’s authorization of Paxlovid requires a prescription. The agency recommends using the drug as soon as possible after a positive COVID-19 test result, specifying it should not be used five days after symptoms develop.

The authorization does not cover the use of the drug as pre-exposure or post-exposure prophylaxis.

“Today’s authorization introduces the first treatment for COVID-19 that is in the f…

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FDA advisory panel to weigh in on molnupiravir

An FDA advisory panel will consider whether emergency use authorization for Merck’s (NYSE:MRK) molnupiravir is warranted. The drug would be the first oral antiviral for COVID-19.

Although the conclusions of the Antimicrobial Drugs Advisory Committee are not binding, FDA generally follows its recommendations.

The benefit-risk calculation for molnupiravir has grown more complicated recently.

Over the Thanksgiving holiday, Merck announced that the drug offered a relative risk reduction of 50% against hospitalization or death. An earlier interim analysis of the Phase 2/3 MOVe-OUT clinical trial found it provided a relative risk reduction of 50%.

Developed in collaboration with Ridgeback Biotherapeutics, molnupiravir is an oral prodrug of the antiviral ribonucleoside analog N-hydroxycytidine (NHC). The drug’s mode of action is to contribute to errors in the viral genome during replication.

FDA has signaled it has questions about the drug’s safet…

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