Pharmaceutical company MSD said on Friday that updated data from its study of the experimental pill for Covid-19 showed the drug is significantly less effective in reducing hospitalizations and deaths than previously reported.
The lab said its pill showed a 30% reduction in hospitalizations and deaths, based on data from more than 1,400 patients. In October, their data showed approximately 50% efficacy, based on data from 775 patients.
Known as Merck in the United States and Canada, MSD asked Anvisa for authorization for emergency use of medicine against Covid this Friday. The company released the data before the Food and Drug Administration (FDA, in free translation) published a series of documents, also this Friday, intended to inform a panel of external experts that will meet on Tuesday (30) to discuss authorization of the pill is recommended.
The body’s members did not make their own recommendations on whether the pill should be authorized. FDA officials asked the panel to discuss whether the drug’s benefits outweigh the risks and whether the population for which it would be authorized should be limited.
They also asked the committee to calculate concerns about whether the drug might stimulate virus mutations, and how those concerns might be alleviated. MSD shares fell 2.8% to $80 (£448) in pre-market trades, amid a slump in markets overall.
Pills such as the MSD drug molnupiravir and a rival drug being developed by Pfizer were considered potential game modifiers as they can be taken into early treatment at home to prevent hospitalizations and deaths.
Data from the Pfizer survey, after analysis of a study involving 1,200 participants, showed an 89% reduction in the risk of coronavirus-related hospitalizations and deaths, compared with a placebo.
MSD applied for US authorization for molnupirvir on Oct. 11, after tentative data. The company said on Friday that data on the drug, developed with Ridgeback Biotherapeutics, had been presented to the FDA ahead of the meeting.
The arm of the study that took molnupirvir had a 6.8 percent rate of hospitalizations and deaths, according to updated data. The placebo group had a 9.7% rate. One patient in the drug group died, compared to nine in the placebo group.
MSD has been in advanced conversations with Fiocruz, since January 2021, to define a model of technical cooperation through its Institute of Technology in Pharmaceuticals (Farmanguinhos/Fiocruz).
The ongoing negotiations between Fiocruz and MSD include the possibility of future studies to evaluate the antiviral in fighting other viral infections, such as dengue and chikungunya.
The drug, developed by MSD in collaboration with Ridgeback Biotherapeutics, already has UK approval and a favorable prior recommendation from the European Medicines Agency, the European Medicines Agency.
It has also been submitted by MSD to other regulatory agencies such as the FDA, EMA and the Japanese Pharmaceuticals and Medical Devices Agency.
Translated by Luiz Roberto M. Gonçalves
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