Lauren Biscaldi is the Managing Editor of Drug Topics. 

Lauren Biscaldi

Merck and Ridgeback Biotherapeutics have announced their submission of an Emergency Use Authorization (EUA) application to the US Food and Drug Administration (FDA) for molnupiravir, an investigational oral antiviral medication for the treatment of COVID-19.

The companies submitted the EUA based on the positive results of a planned interim analysis of the Phase 3 MOVe-OUT trial (NCT04575597) of adults with mild to moderate COVID-19 who were not hospitalized, but were at risk for progression to severe disease and/or hospitalization. Results of the interim analysis indicated that molnupiravir therapy reduced hospitalization and death risk by approximately 50%: only 7.3% of those who received molnupiravir therapy were hospitalized or died compared with 14.1% of those in the placebo group.

No deaths were reported in patients in the molnupiravir treatment group.

Molnupiravir (MK-4483/EIDD-2801) is an investigational, orally administered form of a potent ribonucleoside analog that inhibits replication of SARS-CoV_2.

“The extraordinary impact of this pandemic demands that we move with unprecedented urgency, and that is what our teams have done by submitting this application for molnupiravir to the FDA within 10 days of receiving the data,” said Robert M. Davis, CEO and president of Merck, in a press release. “We look forward to working with the FDA on its review of our application, and to working with other regulatory agencies as we do everything we can to bring molnupiravir to patients around the world as quickly as possible.”

Merck has produced molnupiravir at risk and expects to produce 10 million courses of treatment by the end of 2021. The company is committed to providing timely global access to the drug if authorized or approved, in conjunction with a tiered pricing approach.

1. Merck and Ridgeback announce submission of emergency use authorization application to the U.S. FDA for molnupiravir, an investigational oral antiviral medicine for the treatment of COVID-19. News Release. Merck. October 1, 2021. Accessed October 15, 2021.

Articles

Merck and Ridgeback Biotherapeutics have announced their submission of an EUA application to the FDA for an oral antiviral medication for the treatment of COVID-19. 

Merck, Ridgeback Announce EUA Submission for Investigational Oral Antiviral Molnupiravir for COVID-19

A student pharmacist team from the University of Arkansas for Medical Sciences College of Pharmacy has been selected as the winner of the 18th Annual Good Neighbor Pharmacy (GNP) National Community Pharmacists Association (NCPA) Pruitt-Schutte Student Business Plan Competition.

Runners-up included teams from the University of Texas at Austin College of Pharmacy and the Medical University of South Carolina. All winners were announced as a part of the NCPA 2021 Annual Convention, held October 9 through 12 in Charlotte, North Carolina. These finalists presented their business plans live on October 9, with winners announced the following day.

In an NCPA press release, Brian Caswell, owner of Wolkar Drug in Baxter Springs, Kansas, and NCPA President, applauded each participating team.

“After a highly competitive live competition, one team stood out above the rest. With these well-thought-out business plans, the future of independent pharmacy is in good hands,” he said.

This year’s slate of teams included student pharmacists from 23 schools and colleges of pharmacy across the US who participated in the first-of-its-kind business plan competition. The goal of the competition—named for Neil Pruitt, Sr. and H. Joseph Schutte—is to motivate student pharmacists to “create a business model for buying an existing independent community pharmacy or developing a new one,” according to the press release.

The winning team included team captain Jason Lam and team members Michael Kramer, Bobby Le, and Rachel Murray; Seth Heldenbrand, PharmD, served as team adviser and Cindy D. Stowe, PharmD, as Dean. A prize of $3000 was awarded, with an additional $3000 contribution made to the school in Dean Stowe’s name to promote independent community pharmacy at the UAMS College of Pharmacy.

This article was written in partnership with AmerisourceBergen and Good Neighbor Pharmacy

UAMS College of Pharmacy Wins 2021 Good Neighbor Pharmacy NCPA Pruitt-Schutte Student Business Plan Competition. News Release. National Community Pharmacists Association (NCPA). October 10, 2021. Accessed October 12, 2021. 

https://ncpa.org/newsroom/news-releases/2021/10/10/uams-college-pharmacy-wins-2021-good-neighbor-pharmacy-ncpa

Winners were announced during the NCPA Annual 2021 Convention.