The MSD pharmaceutical company, known as Merck in the United States and Canada, has announced that its experimental drug against COVID-19, MOLNUPINAVIR, reduces by 50% the possibilities of hospitalization and death in patients at risk of developing serious illness. Your data is based on the results of a phase 3 (MOVE-OUT) clinical trial that has stopped to communicate provisional results after detecting the important risk reduction
The company and its partner Ridgeback Biotherapeutics plan to request the authorization of emergency use for the oral antiviral drug as soon as possible, as well as initiating the procedures for approval with the different regulatory agencies.
If it is finally approved, MOLNUPIRAVIR, designed to introduce errors in the genetic code of the virus, would be the first specific oral antiviral for Covid that reaches the market.
"More tools and treatments are urgently needed to combat Covid-19 pandemic that has become one of the main causes of death and continues to affect patients, families and society, stressing health systems in everything The world. With these convincing results, we see with optimism that MOLNUPIRAVIR can become a significant medication as part of the global effort to combat the pandemic and will be added to the SIMD Legacy of MSD to provide discoveries for infectious diseases when more are needed. MSD's firm commitment to save and improve lives, we will continue working with regulatory agencies and we will do everything possible to carry patients mocking as quickly as possible, "he said, in a statement, Robert M. Davis, CEO and president of MSD.
Companies such as Pfizer or Roche are also in the struggle to develop an antiviral pill with good results and simple administration. However, to date, only antibody cocktails have been approved - whose administration must be intravenous - for the treatment of non-hospitalized Covid patients.
An independent analysis of 775 patients participating in the trial carried out by MSD showed that 7.3% of patients who had received MOLNUPIRAVIR needed hospitalization in the 29 days after the administration of the drug, compared to 14, 1% of patients who needed specialized assistance in the placebo group. In the group that received the antiviral, in fact, no death occurred, compared to eight notified in the placebo group.
On the recommendation of an independent data monitoring committee (DATA MONITORING COMMITTEE) and in consultation with the Food and Drug Administration of the United States (FDA), the recruitment of patients has stopped early due to These positive results.
"There is a great need for antiviral treatments that can be taken at home and can keep people with Covid outside the hospital," Wendy Holman, CEO of the company Ridgeback.
In the trial, the analyzed drug of the drug was an intake of a pill every 12 hours for five days.
Patients with mild to moderate COVID were included in the study that presented symptoms for more than five days. All of them had, in addition, some symptom associated with an increased risk of serious illness, such as obesity or advanced age.
Merck says that studies carried out so far indicate that MOLNUPIRAVIR is effective against all circulating variants, including delta.
Although it has not given many details about the safety profile, the company has indicated that the adverse effects detected were similar in the treated group and in the control group.
MSD has also remembered that MOLNUPIRAVIR can not induce genetic changes in human cells.
The company expects to produce 10 million treatment containers for the end of 2021. It already has a contract with the US government to supply 1.7 million dose at a price of $ 700 per dose.
It has also signed an agreement for the manufacture of generics in India, which will provide the drug to countries of scarce and resources.
Date Of Update: 09 October 2021, 06:10
