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FDA grants EUL to Merck's oral molnupiravir for COVID19 treatment

DTMT Network

A day after the United States Food and Drug Administration approved the first oral antiviral drug for the treatment of COVID19, the agency has granted  Emergency Use Authorisation (EUA) for molnupiravir, an experimental oral antiviral on December 23, 2021, an official statement released by the company said.

Molnupiravir has not been approved but has been authorised for emergency use by the FDA under a EUA to treat mild to moderate cases of COVID19 in adults, and who are at high risk of severe infections, including hospitalisation or death, and for whom alternative treatment options are not accessible or clinically appropriate, the statement added.

 “The FDA Emergency Use Authorisation of molnupiravir is an important milestone in the fight against COVID19, and adds to Merck’s legacy of bringing forward innovative medicines that both address the world’s greatest health threats and help save lives,” Robert M. Davis, the chief executive officer and president of Merck said.

Molnupiravir should be administered within five days of symptom onset. The recommended dose for molnupiravir is 800 mg (four 200 mg capsules) taken orally every 12 hours for five days, with or without food. Completion of the full five-day treatment course is important to maximise viral clearance and minimise transmission of SARS-CoV-2, the statement added.

However, Molnupiravir is not recommended for use in patients who are pregnant as findings from animal reproduction studies indicate that molnupiravir may cause fetal harm the company said.


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