Post by icemandios on Feb 16, 2022 20:11:37 GMT
February 16, 2022 02:05 PM ESTUpdated 02:57 PM Pharma
EMA might deny Merck's molnupiravir conditional marketing authorization — report
Paul Schloesser
Associate Editor
While Merck’s Covid-19 antiviral molnupiravir has been given EUA in the US, it has still been pending authorization in Europe. And in a new report from the Financial Times, the EMA might not recommend granting conditional marketing authorization — potentially shutting Merck’s antiviral out of one of the world’s largest drug markets.
People familiar with the approval process told the news organization that the EMA is unlikely to grant conditional marketing authorization to Merck’s Covid-19 antiviral as it wrestles with “problematic” data.
It is “possible” that the oral Covid drug molnupiravir will not receive approval at all, one of the people said.
Merck’s antiviral made headlines last year after a trial suggested that the antiviral drug was 50% effective against death and hospitalization from Covid-19. However, further study showed efficacy to be lower than that — closer to 30%. While the FDA’s Antimicrobial Drugs Advisory Committee narrowly voted 13-10 back in December in favor of the pill, citing its benefits outweighing the risks for adults within 5 days of developing Covid symptoms, a summary of the meeting shows that the committee members who voted “No” against the pill cited the following reasons as to why: 1) a high number-needed-to-treat compared with placebo, 2) unclear efficacy against the Delta variant, 3) potential to drive viral mutations, and 4) mutagenicity risks.
The EMA gave the antiviral a preliminary nod last year after reviewing initial data, allowing EU member states to prescribe the drug before marketing authorization was given — something that Merck noted in a statement to Endpoints News.
“We believe a range of medicines and vaccines are needed to make an impact on the pandemic and that it’s important in medicine to have a selection of treatments available for various patient groups,” Merck said to Endpoints. “We are very confident in the clinical profile of molnupiravir and are moving with rigor and urgency to bring this medicine forward to patients around the world.”
Regarding the EMA: A Merck spokesperson said, “We are in active discussions with regulators with aim of bringing molnupiravir to patients in Europe as quickly as possible.”
And while the FDA restricted molnupiravir’s use in patients under the age of 18 and prevented use for more than 5 consecutive days, French regulators declined to give molnupiravir the OK amid efficacy concerns and the potential impact of the Omicron variant. The country later canceled its order.
Merck said on an earnings call late last year that it expected $5 billion to $6 billion in sales for the drug in 2022.
A person familiar with the EMA approval process told the Times that the drug had been “a bit of a disappointment” and that 30% efficacy “started to be on the limits of [what is considered] benefit.” Some US pharmacies have been reporting that they have been running out of space to store the pill — because so few people are using it.
Rather, people are being prescribed both Pfizer’s pill Paxlovid and GSK/Vir’s monoclonal antibody sotrovimab for use ahead of molnupiravir — making the antiviral essentially a third-line treatment.
Merck’s share price has remained almost exactly the same, with $MRK closing at $77.84 yesterday and opening this morning at $77.17.
According to European officials, healthcare systems in Europe are also favoring Paxlovid, which has reported 89% efficacy in reducing death and hospitalization
EMA might deny Merck's molnupiravir conditional marketing authorization — report
Paul Schloesser
Associate Editor
While Merck’s Covid-19 antiviral molnupiravir has been given EUA in the US, it has still been pending authorization in Europe. And in a new report from the Financial Times, the EMA might not recommend granting conditional marketing authorization — potentially shutting Merck’s antiviral out of one of the world’s largest drug markets.
People familiar with the approval process told the news organization that the EMA is unlikely to grant conditional marketing authorization to Merck’s Covid-19 antiviral as it wrestles with “problematic” data.
It is “possible” that the oral Covid drug molnupiravir will not receive approval at all, one of the people said.
Merck’s antiviral made headlines last year after a trial suggested that the antiviral drug was 50% effective against death and hospitalization from Covid-19. However, further study showed efficacy to be lower than that — closer to 30%. While the FDA’s Antimicrobial Drugs Advisory Committee narrowly voted 13-10 back in December in favor of the pill, citing its benefits outweighing the risks for adults within 5 days of developing Covid symptoms, a summary of the meeting shows that the committee members who voted “No” against the pill cited the following reasons as to why: 1) a high number-needed-to-treat compared with placebo, 2) unclear efficacy against the Delta variant, 3) potential to drive viral mutations, and 4) mutagenicity risks.
The EMA gave the antiviral a preliminary nod last year after reviewing initial data, allowing EU member states to prescribe the drug before marketing authorization was given — something that Merck noted in a statement to Endpoints News.
“We believe a range of medicines and vaccines are needed to make an impact on the pandemic and that it’s important in medicine to have a selection of treatments available for various patient groups,” Merck said to Endpoints. “We are very confident in the clinical profile of molnupiravir and are moving with rigor and urgency to bring this medicine forward to patients around the world.”
Regarding the EMA: A Merck spokesperson said, “We are in active discussions with regulators with aim of bringing molnupiravir to patients in Europe as quickly as possible.”
And while the FDA restricted molnupiravir’s use in patients under the age of 18 and prevented use for more than 5 consecutive days, French regulators declined to give molnupiravir the OK amid efficacy concerns and the potential impact of the Omicron variant. The country later canceled its order.
Merck said on an earnings call late last year that it expected $5 billion to $6 billion in sales for the drug in 2022.
A person familiar with the EMA approval process told the Times that the drug had been “a bit of a disappointment” and that 30% efficacy “started to be on the limits of [what is considered] benefit.” Some US pharmacies have been reporting that they have been running out of space to store the pill — because so few people are using it.
Rather, people are being prescribed both Pfizer’s pill Paxlovid and GSK/Vir’s monoclonal antibody sotrovimab for use ahead of molnupiravir — making the antiviral essentially a third-line treatment.
Merck’s share price has remained almost exactly the same, with $MRK closing at $77.84 yesterday and opening this morning at $77.17.
According to European officials, healthcare systems in Europe are also favoring Paxlovid, which has reported 89% efficacy in reducing death and hospitalization