FDA; US Food and Drug Administration voted 13-10 to recommend the immediate use of a pill made by Merck and Ridgeback Biotherapeutics to help treat Coronavirus patients.
The gatering witnessed a split decesion between members of the FDA's Antimicrobial Drugs Advisory Committee that recommends molnupiravir, which can reduce the risk of sever symptoms or death by 30%. 3% -- 9.7% of people who took placebo died, compared to 6.8% of those given molnupiravir.
The pills would be the first oral treatment to prevent Covid-19. It comes in capsule form.
The use of the drug must be at least five days when the first symptoms start to show and it has to be taken at least twice a day for the aformentioned time frame, however members of the committee were not certain about risks to pregnant women.
"I vote no. Based on the currently available data I think I just need more efficacy and safety data, perhaps by with more subjects against placebo or other treatment strategies, before I can vote yes," said Jennifer Le, professor of clinical pharmacy at the University of California, San Diego.
"I don't think I would want to take this drug, not knowing the effects it would have on my unborn child," said Roblena Walker, the consumer representative on the committee.
"I voted yes because Covid-19 is still an emergency situation. As a frontline clinician in treating patients, both inpatient and outpatient, there is a need for something like this," said Dr. W. David Hardy of the Charles Drew University School of Medicine and Science in Los Angeles. "Although I do have questions about its overall, longer term efficacy, it did meet its pre-specified statistical boundaries of showing a 48% improvement in terms of hospitalization and death." he added.
The majority of the committee members said they hoped Merck would be asked to continue gathering information on the pill.
"I see this as an incredibly difficult decision and as already been stated, there are many, many more questions than answers," said Dr. Lindsey Baden, director of clinical research division of infectious diseases at Brigham and Women's Hospital in Boston, who voted yes.
"Overall, I trust our practitioners that if we educate them properly, they can deploy this properly," Baden added.
"The final dataset still indicate a 30% reduction in hospitalization and death with a noticeable reduction in death cases that motivated me towards the yes vote," said Dr. George Siberry, medical officer at the US Agency for International Development,
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