Merck asks EMA to reevaluate rejected Covid-19 antiviral
Merck is seeking a reevaluation of the European Medicines Agency’s (EMA) rejection of the pharma’s blockbuster Covid-19 pill, known as Lagevrio (molnupiravir), which has served as a second option to Pfizer’s Paxlovid (nirmatrelvir/ritonavir).
The EMA announced its long-awaited rejection in late February, saying publicly:
Based on the totality of data, it was not possible to conclude that Lagevrio can reduce the risk of hospitalisation or death or shorten the duration of illness or time to recovery in adults at risk of severe disease. Furthermore, it was not possible to identify a specific group of patients in whom a clinically relevant benefit of Lagevrio could be demonstrated.
In the US, Merck’s Covid drug has been available under emergency use authorization since Dec. 2021, with the US reporting more than 1.2 million courses of the drug administered so far and another 1.7 million courses have been delivered to states.
The FDA in late February, according to a review memo, took another look at Lagevrio’s EUA after Michael Lin, Stanford University associate professor, requested a re-review following the release of a preprint article uncovering “a signature of molnupiravir mutagenesis” that can be seen “in global sequencing databases, in some cases with onwards transmission.”
Molnupiravir hype: useful antiviral drug, won't create viable viral mutants
Molnupiravir reality: useless antiviral drug, creates viable viral mutants@FDACDERDirector please reconsider the EUA, for the sake of public health
— Michael Lin, MD PhD 🧬 (@michaelzlin) February 22, 2023
But the FDA, meanwhile, took a look and all but dismissed the article, acknowledging in its review memo that while it’s “plausible that MOV [molnupiravir] use could contribute to mutational patterns in SARS-CoV2 sequences, there are some uncertainties regarding the authors claims and the public health implications of their results that are transmissible remains challenging to quantify.”
Merck also noted, according to the memo, that the authors of the preprint “assume that the observed SARS-CoV-2 mutations are associated with MOV treatment, relying on circumstantial associations between viral sequence origin and timeframe of sequence collection in countries where MOV is available, with no direct evidence that the viral sequences arose from MOV use.”
In 2022, Merck sold about $5.7 billion of Lagevrio worldwide. And the big biopharma company predicts another $1 billion in sales for this year.