Merck is fighting to win European approval for Covid antiviral pill
Merck is fighting to win European approval for Covid antiviral pill

Merck is fighting to win European approval for Covid antiviral pill

It is unlikely that the European Medicines Agency will grant conditional marketing authorization to Merck’s Covid-19 antiviral pill this month, as it is struggling with “problematic” data, according to people familiar with the approval process.

It is “possible” that the oral Covid drug molnupiravir will not receive approval at all, said one person. The EMA declined to comment on its ongoing review.

Merck’s drugs raised new hopes and sent shares in the company to rise late last year after early data from a late trial suggested it halved the risk of death and hospitalization.

However, a subsequent analysis revealed that its efficiency was lower than previously assumed, at 30 per cent. The U.S. Food and Drug Administration has given its approval, but restricted its use. France canceled his order for the drug due to concerns about efficacy.

A person familiar with the EMA approval process said at the time that the drug had been “a bit of a disappointment” and that 30 percent efficiency “Started to be on the verge of [what is considered] advantage”.

In response to questions, the regulator pointed to a statement in November stating that it “could issue an opinion [an approval] within weeks if the data submitted is sufficiently robust and complete ”.

According to European officials, national health systems in Europe favor Pfizers Paxlovid, another Covid antiviral pill whose effectiveness in reducing deaths and hospitalization has been confirmed at 89 percent.

Merck, who developed molnupiravir with partner Ridgeback Biotherapeutics, said it was in active discussions with regulators with the aim of bringing the drug to patients in Europe as soon as possible.

The US company said it was “very convinced” of the clinical profile of molnupiravir and believed a range of drugs and vaccines were needed to tackle the pandemic.

Molnupiravir has a low propensity for drug interactions, making it a meaningful and important option for appropriate patients with Covid-19 who are receiving treatment for underlying conditions such as heart disease, hypertension, diabetes and … liver or kidney failure, said Merck.

The United Kingdom, which has raised 2.23 million courses of the drug, implement it in clinical trials. It remains a third-line option, meaning its use is recommended after other drugs have failed or are not considered suitable.

The EMA had given it a preliminary nod last year in light of the initial positive data, which allowed Member States to prescribe it. A review of the entire dataset was expected to complete last month, Emer Cooke, CEO of EMA, told the Financial Times last year.

In the United States, where 1.5 million course of Merck’s antiviral pill has been distributed to pharmacies and health centers since late December, the demand for patients has been weak, according to doctors and pharmacists, who mentioned its “striking difference” in effectiveness compared to Paxlovid and concerns. about possible side effects.

Delays in diagnosing Covid had also complicated the rollout because the drug had to be taken within five days of infection, they said.

U.S. health officials warned last week that some pharmacies were running out of storage space for the drug just weeks after distribution began due to weak demand.

“Unless we are forced to use molnupiravir, we would much rather use Paxlovid or sotrovimab – so it’s a bit on our shelves,” said Christian Ramers, an infectious disease specialist at the Family Health Centers in San Diego.

He said Merck’s antiviral pill tended to be an option being considered for people who had significant drug-to-drug interactions and therefore could not use Paxlovid.

Analysts said the slow uptake of molnupiravir in the US was unlikely to affect revenue in the short term for Merck, which has forecast $ 5-6 billion. USD in sales in 2022 based on signed agreements. But future demand would suffer unless Merck was able to provide better clinical data.

“Given the current data on clinical outcomes, there are several therapies that are preferred over molnupiravir,” said Daina Graybosch, an analyst at SVB Leerink, referring to Paxlovid, Gilead Sciences’ remdeivir – an antiviral drug administered by injection – and monoclonal antibody therapy. sotrovimab from GlaxoSmithKline and Virginia. and Eli Lilly’s bebtelovimab.

Merck said it expected to report results on a global study evaluating molnupiravir’s ability to prevent Covid by mid-year. The company continues to share data with the regulator on its clinical trials with non-hospitalized adults and is participating in a UK trial with more than 8,500 participants.

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