American drugmaker Merck has stated that the latest data on its Covid-19 treatment showed the pill to be less effective than initially reported, just days before a panel meeting where US regulators will review the new drug.
Merck announced on Friday that new data showed a lower efficacy of its Covid-19 pill, which aims to reduce virus-related hospitalizations and deaths, than previously reported. Last month, the pharma firm said the antiviral drug, molnupiravir, showed around a 50% efficacy level, while Friday’s figures showed that figure was 30%.
The company’s update came as the US Food and Drug Administration (FDA) released details of its analysis of the medication so far. The agency is to hold a public meeting on November 30 to consult outside experts on the new drug’s safety and efficacy.
The FDA said its scientists found the drug to be effective against Covid, but they also identified a number of possible health risks from the experimental treatment including potential birth defects. It wants the independent expert group to discuss these concerns, the AP reported, though it is not obliged to take the advice on board.
The discussion will also weigh whether the drug’s benefits outweigh its risks. The FDA said that Merck has already agreed that the medication is not intended to be used by children.
There are also concerns about the fact that the new drug led to small changes in the Covid-19 signature spike protein, which the virus uses to enter human cells. In theory this could mean the creation of dangerous new mutations, the agency noted, as per AP. Additionally, it turns out that Merck collected less safety data on this drug than for other Covid-19 therapies, FDA regulators observed.
If given the green light, Merck’s drug would be the first Covid-19 pill in the US that could be taken at home to promote a speedy recovery. Earlier this month, the UK became the first country to authorize the drug for emergency use only.