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FDA Approves Merck’s COVID-19 Pill

By Antonio Gozain | Fri, 12/24/2021 - 12:48

The US Food and Drug Administration (FDA) approved Merck’s molnupiravir COVID-19 pill for certain high-risk adult patients, one day after approving Pfizer’s pill, reported The Washington Post.

“Today’s authorization provides an additional treatment option against the COVID-19 virus in the form of a pill that can be taken orally. Molnupiravir is limited to situations where other FDA-authorized treatments for COVID-19 are inaccessible or are not clinically appropriate and will be a useful treatment option for some patients with COVID-19 at high risk of hospitalization or death,” said in a press release Patrizia Cavazzoni, Director, FDA Center for Drug Evaluation and Research.

Unlike COVID-19 vaccines, which target the spike protein on the outside of the SARS-CoV-2 virus, molnupiravir targets an enzyme that the virus uses to copy itself. The pill prevents the virus from multiplying by introducing errors into its RNA. In early November, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) approved Merck’s drug. “Following a rigorous review of the data by our expert scientists and clinicians, we are satisfied that molnupiravir is safe and effective for those at risk of developing severe COVID-19 disease and have granted its approval,” said June Raine, Chief Executive, MHRA.

In addition to the commercialization of molnupiravir in developed countries where it is already approved for its emergency use, Merck signed a royalty-free agreement with the UN-backed Medicines Patent Pool for its pill. Thanks to this voluntary deal, molnupiravir will be manufactured and sold cheaply in countries where vaccines are in short supply, as reported by MBN. Generic drugmakers in developing countries will be able to market the COVID-19 pill for US$20 per treatment, which lasts five days, compared to the US$712 that the US government agreed to pay Merck for its initial purchase.

Will Molnupiravir Become Available in Mexico?

The pill’s arrival to Mexico depends on both the government and the regulatory agency, COFEPRIS, reported MBN.

“We are prepared and committed to sit down and talk with the government and COFEPRIS. Regulatory agencies are autonomous and independent; COFEPRIS has world-class certifications and can act autonomously. (Molnupiravir) will surely arrive for emergency use, for government use in public institutions. We are ready to have the conversation (with authorities), of course, never losing sight of the most important part, universal access to health,” said Javier Báez-Villaseñor Moreno, Associate Director, Government Vaccines, Medical Affairs, Merck México.

The data used in this article was sourced from:  
MBN, The Washington Post, FDA
Antonio Gozain Antonio Gozain Journalist and Industry Analyst