x

Science

Final US Hurdle for Merck’s COVID-19 Pill: FDA Panel Review

November 30, 2021

WASHINGTON — An experimental COVID-19 drug that could soon become the first U.S.-authorized pill to treat the coronavirus faces one final hurdle Tuesday: A panel of government experts will scrutinize data on the medication from drugmaker Merck.

The Food and Drug Administration is asking its outside experts whether the agency should authorize the pill, weighing new information that it is less effective than first reported and may cause birth defects. The panel’s recommendations aren’t binding but often guide FDA decisions.

Tuesday’s meeting comes as U.S. infections are rising again and health authorities worldwide scramble to size up the threat posed by the new omicron variant.

If authorized, Merck’s pill would be the first that U.S. patients could take at home to ease symptoms and speed recovery, a major step toward reducing hospital case loads and deaths. The drug, molnupiravir, is already authorized for emergency use in the U.K.

Given the ongoing threat of the pandemic the FDA is widely expected to approve emergency use of Merck’s pill. But new data released last week paint a less compelling picture of the drug than when the Merck first publicized its early results in October.

On Friday, Merck said final study results showed molnupiravir reduced hospitalization and death by 30% among adults infected with the coronavirus, significantly lower than the 50% reduction it first announced based on incomplete results.

FDA regulators said they were still reviewing Merck’s update and would present a new assessment of the drug’s benefits to the outside panel. Molnupiravir’s effectiveness is a key question as panel members weigh whether to recommend the drug and for whom.

One key question is whether the drug should be restricted from use in pregnant women or women of child-bearing age.

In its safety review, FDA staffers said animal studies suggested Merck’s drug could cause birth defects when given at high doses. Regulators said they are considering a complete ban on molnupiravir’s use during pregnancy and other safeguards, including recommending contraceptives for some patients taking the pills.

Merck’s drug uses a novel approach to fight COVID-19: it inserts tiny errors into the coronavirus’ genetic code to stop the virus from reproducing. That genetic effect has raised concerns that the drug could cause mutations in human fetuses or even spur more virulent strains of the virus.

Another key question is whether the drug should be offered to patients who have been vaccinated or previously had COVID-19. Merck didn’t study the drug in vaccinated people, but data from a handful of patients with prior infections suggested it had little benefit. Still, it may be impractical for doctors to screen out those patients. The Merck drug works best when given within five days of first COVID-19 symptoms, underscoring the need for speedy treatment.

Merck tested the drug in adults with mild-to-moderate COVID-19 who were considered higher risk due to health problems like obesity, diabetes or heart disease. That’s the same group that currently receives antibody drugs, which help the immune system fight the virus. The FDA has authorized three antibody drugs for COVID-19 but all have to given by IV or injection at hospitals or clinics.

Merck was the first company to submit its COVID-19 pill to the FDA, but a rival drug from Pfizer is close behind and is also under review.

Pfizer’s drug is part of a decades-old family of antiviral pills known as protease inhibitors, a standard treatment for HIV and hepatitis C. They work differently than Merck’s pill and haven’t been linked to the kind of mutation concerns raised with Merck’s drug.

RELATED

ATHENS - It’s been decades since the AIDS crisis broke out and spread fear about unprotected sex and promiscuity but data from Greece’s National Public Health Organization (EODY) found that sexually-transmitted diseases are rising.

Top Stories

Columnists

A pregnant woman was driving in the HOV lane near Dallas.

General News

NEW YORK – Meropi Kyriacou, the new Principal of The Cathedral School in Manhattan, was honored as The National Herald’s Educator of the Year.

Video

Firefighters Seek to Corral Massive Texas Wildfires Before Weekend of Higher Temperatures and Winds

CANADIAN, Texas (AP) — The explosive growth of the second-largest wildfire in Texas history slowed as winds and temperatures dipped but the massive blaze was still untamed and threatening more death and destruction.

BROWNSVILLE, Texas  — On the banks of the same Rio Grande but 300 miles apart, President Joe Biden and GOP challenger Donald Trump on Thursday surveyed the U.

MOSCOW (AP) — Russian President Vladimir Putin vowed Thursday to fulfill Moscow’s goals in Ukraine and sternly warned the West against deeper involvement in the fighting, saying that such a move is fraught with the risk of a global nuclear conflict.

ATHENS - The greatest problem in Greece following the restoration of democracy in Greece is the missed opportunities, Prime Minister Kyriakos Mitsotakis said on Thursday evening in a discussion at the "Metapolitefsi: 50 Years Later" conference, which focuses on the fifth-decade anniversary of the restoration of democracy in Greece.

NEW YORK – The Greek Orthodox Folk Dance & Choral Festival Ministry of the Metropolis of San Francisco is dedicated, through Orthodox Christian Fellowship and committed leadership, to promoting, encouraging and perpetuating the Orthodox faith, Greek heritage and culture among individuals, families and communities by expressing it through folk dance, folk art, music and language.