MSD said Friday that the company plans to supply molnupiravir, its oral Covid-19 therapy under development, to Korea by receiving emergency use authorization (EUA) from the local regulatory agency.
MSD’s move comes as the Korean government negotiates with global pharmaceutical companies to import oral Covid-19 treatments before January or February.
“We are consulting with the Ministry of Food and Drug Safety (MFDS) to apply for emergency use authorization,” an MSD official said. “We will closely work with the Korean government so that molnupiravir can be used quickly for Korean Covid-19 patients in the early stage of infection.”
On Tuesday, Yoo Young-min, chief of staff to President Moon Jae-in, told the National Assembly that the government would secure about 400,000 doses of oral Covid-19 therapies. “Oral treatments will not be given to all confirmed patients but selectively prescribed for patients progressing to severe condition,” Yoo said. “We believed that estimated 400,000 doses would be enough for now.”
Molnupiravir is the fastest drug that seeks a EUA from the U.S. regulator among oral Covid-19 treatments.
MSD applied for the EUA of molnupiravir with the U.S. Food and Drug Administration on Oct. 11. The FDA plans to hold an advisory meeting on Nov. 30 to review the safety and effectiveness of the drug.
On Monday, European Medicines Agency (EMA) also initiated a rolling review for molnupiravir in adults at risk. MSD plans to work with the EMA’s Committee for Medicinal Products for Human Use (CHMP) to complete the rolling review process to facilitate formal review.
MSD developed the drug for treating at-risk adults with mild-to-moderate Covid-19 symptoms. However, its high price will initially limit its use to older adults or those with underlying diseases. One set of molnupiravir for five-day treatment is priced at about 820,000 won ($700).
According to an interim analysis of phase 3 clinical trial on 775 of 1,550 mild-to-moderate patients, molnupiravir lowered hospitalization or mortality risk by nearly 50 percent. In addition, no deaths were reported in the molnupiravir group, while eight patients who were given a placebo in the trial later died the disease.
MSD pointed out that molnupiravir could be the first oral antiviral medicine for Covid-19 that will play a key role in the fight against the pandemic once it receives authorization.
The company said it is actively working with regulatory agencies worldwide to submit applications for emergency use or marketing authorization in the coming months.