By
Godfrey Benjamin
October 4th, 2023
Merck is seeking authorization for emergency use of molnupiravir, an oral administration for early-stage COVID-19 patients. It is in talks with regulators worldwide.
On Monday, October 10, pharmaceutical giant Merck & Co Inc (NYSE: MRK) requested the US Food and Drug Authorization for the authorization of the emergency use of its experimental antiviral pill that treats mild to moderate COVID-19 in adults. By now, there is no reaction to the news from the company’s MRK stock in the pre-market.
Last week, the US drugmaker released the Phase 3 clinical trial data. The Merck pill dubbed Molnupiravir reduces the chances of hospitalization of newly recognized COVID-19 patients by 50%. This drug works by inhibiting the replication of the virus inside the body of the patient.
Unlike the intravenous drug Remdesivir from Gilead Sciences, Merck’s Molnupiravir can be administered orally. This could also be a potentially game-changing advancement in the fight against the COVID-19 virus. As of now, America is reporting 1600 COVID-19 deaths on a daily basis. Speaking of this development, Merck CEO Robert Davis said:
“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.”
The pill could be available to American citizens by late 2021. Merck has developed this drug in partnership with Ridgeback Biotherapeutics. The pharma giant also noted that it is working with regulatory agencies worldwide for emergency use.
Merck Gearing Up for Pill Production & Supply
Earlier this year, Merck agreed to supply 1.7 million doses of Molnupiravir in America. Of course, this was subject to full approval by the FDA and authorization for emergency use. Earlier this month on October 1, the findings of the trial showed phenomenal results. Post that, the MRK stock also gained 11%.
As per a NY Times report, a five-day dosage of Molnupiravir will cost the US Federal government $700 per patient. This is one-third of the cost that the current government is spending on monoclonal antibodies. Besides, several US health officials are also positive about Merck’s pill. They noted that it will help in faster recovery among patients and prevent trips to the hospital.
Dr. Mike Ryan, executive director of the World Health Organization’s Health Emergencies Program, said pills like Merck’s serves as a “holy grail” of treatments. Apart from Merck other drugmakers are also working on antiviral pills. Developments in this regard will be interesting to watch.