The aspects to be clarified
If this drug is approved, it will significantly change the landscape of anti Covid therapy, but there are still aspects that need to be clarified, such as the side effect profile or the dosage in different populations such as children and the obese.
Only limited information on side effects was made public in the press release, but the companies said the rates were similar between the placebo group and the treated group. An adverse event, or a negative outcome, occurred in 35% of those who received molnupiravir and 40% of those who received placebo. Only 1.3% of molnupiravir.treated subjects discontinued the drug due to an adverse event, compared with 3.4% who discontinued placebo.
Access to the drug
Before obtaining the results of the MOVe.OUT study (conducted in over 170 centers worldwide), MSD has already started the production of molnupiravir, with the aim of reaching 10 million doses by the end of 2021.
In the months leading up to today’s announcement, MSD entered into a procurement agreement with the United States government; Under the agreement, MSD will provide approximately 1.7 million doses of molnupiravir to the US government once an agreement is reached for emergency use or approval of the drug. , MSD is entering into purchasing and supply agreements with other governments worldwide, always conditional on regulatory authorization, and discussions are underway with many other governments.
As part of its commitment to global access, MSD has already announced that it has signed non.exclusive voluntary licensing agreements with established generic drug manufacturers to accelerate the availability of the new antiviral in more than 100 low. or middle.income countries. basis of an existing emergency use approval or authorization issued by local regulatory agencies.