NETHERLANDS — Merck is appealing the EMA’s rejection of its Covid-19 pill, Lagevrio, which serves as an alternative to Pfizer’s Paxlovid.

The EMA stated that they couldn’t conclude that Lagevrio reduces the risk of hospitalization or death or shortens the duration of illness or time to recovery in adults at risk of severe disease.

However, the drug has been available under emergency use authorization in the US since Dec. 2021, with over 1.2 million courses administered and another 1.7 million delivered to states.

The FDA re-reviewed Lagevrio’s EUA after a Stanford University professor’s request based on a preprint article revealing “a signature of molnupiravir mutagenesis” seen in global sequencing databases.

The FDA reviewed a preprint article regarding the mutational patterns in SARS-CoV2 sequences and acknowledged that it’s plausible that the use of molnupiravir could contribute to these patterns.

However, there are uncertainties regarding the claims and their public health implications, making it challenging to quantify the transmissibility of these mutations.

Merck also pointed out that there’s no direct evidence that the observed viral sequences arose from the use of molnupiravir.

The FDA has granted full approval for Pfizer-BioNTech’s Covid-19 vaccine for people aged 16 and older, as well as for Moderna’s vaccine for people aged 18 and older.

These approvals have led to increased vaccination rates, with over 200 million Americans now fully vaccinated against Covid-19.

Merck’s Molnupiravir setback does not negate the company’s advantage in the market, thanks to its highly profitable cancer drug, Keytruda (pembrolizumab), which generated nearly US$21 billion in revenue in 2022 alone.

Despite its rocky start, Keytruda has since been approved for a wide range of cancers, although there is evidence of certain cancers that do not respond to the therapy.

To maximize resources, Merck may need to fine-tune its approach and investigate factors such as genomic subtypes and the gut microbiome’s effect on Keytruda’s efficacy.

While Merck did shut down certain clinical trials, including KEYNOTE-641, the company remains competitive in the oncology market.

As Keytruda goes off-patent by 2028, it will be interesting to see how Merck and its competitors adapt to emerging oncology data.

Meanwhile, Merck & Co. has partnered with Opko Health to potentially develop the first Epstein-Barr virus vaccine.

The deal is worth up to US$922.5 million, with Merck taking over clinical, regulatory, and commercial activities related to the vaccine once a joint application is filed with Opko unit ModeX Therapeutics.

Opko will receive an upfront payment of US$50 million and milestone payments of up to US$872.5 million, as well as royalties on global sales.

Currently, there is no vaccine for the Epstein-Barr virus, which is the leading cause of mononucleosis. Following the announcement of the deal, Opko’s shares rose by as much as 24%.

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