WASHINGTON, Nov 27 ― An anti-Covid pill developed by Merck has proved effective in treating the disease, the US Food and Drug Administration said yesterday in a much-awaited preliminary report. But the report, from an FDA advisory panel, cautioned that pregnant women should not use the...
channel for the latest updates.WASHINGTON, Nov 27 ― An anti-Covid pill developed by Merck has proved effective in treating the disease, the US Food and Drug Administration said yesterday in a much-awaited preliminary report. But the report, from an FDA advisory panel, cautioned that pregnant women should not use the drug, known as molnupiravir, saying the potential benefits do not outweigh the risks for those patients.
The report is meant to provide guidance to an FDA experts panel convening Tuesday to consider whether to authorise emergency use of molnupiravir.Approval, analysts say, would represent a major step forward in the battle against the global pandemic, handing healthcare professionals a powerful new tool to help those infected.
Merck released the full results of the drug's clinical trial yesterday, which found the pill would reduce by 30 per cent ― much lower than its initial figure ― the rate of hospitalisations and deaths in high-risk Covid patients who took it soon after infection. headtopics.com
The preliminary FDA report confirmed the drug's effectiveness in patients with mild to moderate Covid or at risk of hospitalisation.In adding a caution against the drug's use by pregnant women, the report noted that no pregnant women were included in the clinical trials.
But it said tests involving pregnant rats and rabbits found higher rates of developing underweight and malformed foetuses after taking the drug.It cited “both known and possibly unknown risks ... in pregnant or lactating individuals and pediatric patients.”
Merck, in its authorisation request, said its data stemmed from trials conducted in partnership with Ridgeback Biotherapeutics in people with mild to moderate cases of Covid-19 and with at least one additional risk factor.They were given the drug within five days of symptoms first appearing.
Merck initially said the drug, in a clinical trial, had been found to halve the rate of hospitalizations and deaths, before decreasing the rate in yesterday's full results.Those interim results were produced on the basis of studying slightly more than 700 patients, half of whom received the pill and half of whom got a placebo. headtopics.com
The finding ― a 48 per cent reduction rate ― was statistically significant, and considered persuasive enough that an independent data review committee decided, in consultation with the FDA, to halt the drug trial ahead of schedule.The full results were based on analysis of more than 1,400 patients, resulting in the more modest reduction rate of hospitalisation and death.
Both the interim and complete results “support the efficacy and overall favourable benefit-risk assessment of molnupiravir” for treating mild to moderate Covid-19 in high risk adults, Merck said in a press release.The full results found the hospitalisation rate among patients who received the drug was 6.8 per cent, compared to 9.7 per cent for those given a placebo.
Just one of those treated died, while the second group saw nine deaths.Antiviral drugs like molnupiravir work by reducing the ability of a virus to reproduce itself.The drugs may be useful not only in keeping infected people from developing more serious symptoms, but in preventing people who have had prolonged exposure to the virus from falling ill.
The pill can be dispensed by a pharmacy and taken at home, whereas the three authorised monoclonal antibodies authorised for treating mild to moderate Covid-19 in at-risk individuals must be administered intravenously or through injection, the FDA report noted. ― AFP headtopics.com
You May Also LikeRead more: Malay Mail »
Khazanah striving for ‘Advancing Malaysia’
KUALA LUMPUR (Jan 22): Khazanah Nasional Bhd is no longer the country’s largest sovereign wealth fund. But as Malaysia’s strategic investment arm, it is expected to do more to help the nation rebound stronger and close gaps worsened by Covid-19 while delivering decent dividends to the government.In his first interview as Khazanah's managing director, Datuk Amirul Feisal Wan Zahir said the mandate never really changed, though the focus may differ during different phases of development.On top of the recently announced Dana Impak — Read more >>
Ringgit extends downtrend against US dollar at opening | Malay MailKUALA LUMPUR, Nov 25 — The ringgit extended its downtrend for the fourth consecutive day to open lower against the US dollar amid expectations for a faster tapering process and possible rate hikes by the Federal Reserve, an analyst said. At 9am, the local note weakened to 4.2130/2160 versus the...
Respite for Biden as US layoff wave ebbs, spending ramps up | Malay MailNEW YORK, Nov 25 — Americans are spending their way into the holiday season, while jobless claims have fallen to historic lows, new data showed Wednesday — offering some respite for President Joe Biden as he steers the recovery from the Covid-19 pandemic amid soaring inflation. The raft of...
Black Friday ‘early birds’ find US stores less crowded, fewer bargains | Malay MailCHICAGO, Nov 26 — Bargain hunters ventured out in chilly weather to buy Christmas gifts on Black Friday, finding stores less crowded than in years past as major US retailers opened their doors early. A shift online, Covid fears and less-steep discounts have thinned crowds on the day after the US... Muhammad Qasim’s dreams are a warning to the Muslim ummah. As they are coming true, many across the world are talking about them, and newspapers and interviews are also being conducted on these dreams. Learn more at or search ‘Muhammad Qasim Dreams’ A prediction in Qasim’s dream – a large star or comet will be in the solar system, on course towards the sun, and as it passes by the Earth, it will put the entire earth in complete darkness. Many of Qasim’s dreams are coming true already. More at
US retail stocks slide on Black Friday as new coronavirus worries arise | Malay MailNEW YORK, Nov 26 — Shares of US department-store operators slid today as the detection of a new coronavirus variant possibly resistant to existing vaccines compounded woes stemming from low in-store visits and thin holiday season inventories. Retailers have turned Black Friday, which kicks off... Muhammad Qasim telah menyaksikan peristiwa menjelang Kiamat, termasuk Perang Dunia ke-3, Ghazwa e Hind, Ketibaan Dajjal, Kembalinya Isa A.S, keluarnya Ya’juj & Ma’juj, dan masa Imam Mahdi. Banyak gambaran dalam mimpi Qasim menjadi kenyataan. Silakan layari Muhammad Qasim has seen Prophet Muhammad SAW in grief and despair over the state of Muslims and his religion, Islam. Qasim has seen divine dreams for over 43 years and his dreams have many warnings for the time to come. More at
Report: Beijing asks ride-hailing giant Didi to delist from USRegulators in China have asked ride-hailing giant Didi to draw up a plan to delist from the United States over data concerns, a report said Nov 26, as Beijing continues its tight scrutiny of domestic tech giants. Alibaba next Jack in a box
US webcam model accidentally shoots herself in the vagina and survives | Malay MailKUALA LUMPUR, Nov 26 — A webcam model, who accidentally shot herself in the vagina while recording a video at her home, miraculously survived the shooting. The model, Lauren Hunter Daman, 27, was alone in her room when the firearm was discharged in Thomaston, Georgia, USA, Daily Star reported....