Sat. May 28th, 2022

Merck defends the safety profile of its Covid antiviral pill and claims a competitive treatment developed by Pfizer will create problems for some patients who use drugs for other medical conditions.

Criticism of a competitor’s product from Merck comes as the U.S. Food and Drug Administration considers whether its antiviral drug molnupiravir, the first easy-to-administer oral treatment for Covid-19, is authorized.

Last week, a panel of external experts at the FDA voted narrowly in favor of giving the green light to Merck’s drug with a margin of 13 to 10. But some members have expressed concern about its efficacy and safety, including whether it can cause birth defects if taken by pregnant women or possibly can help cultivate new Covid varieties.

In an interview with the Financial Times, Eliav Barr, senior vice president of global medical affairs at Merck, said both antiviral drugs are needed to protect people from the virus, as some patients may not be able to take any of the treatments. not. to possible side effects.

However, requiring Pfizer’s antiviral pill to be taken with ritonavir, a drug used to treat HIV, would make the treatment unsuitable for many people with pre-existing medical conditions, he added.

“Ritonavir, which has been used in HIV therapy for many years, is a drug that specifically inhibits the body’s ability to break down drugs,” Barr said. “The problem is that it is incredibly non-specific. So there is a whole range of medicines that people take, especially those medicines, unfortunately, that are associated with conditions that involve risk. ”

N study published In the scientific journal Nature last week, a ‘high overall frequency’ of drug-to-drug interactions was identified in high-risk Covid-19 patients in Spain who were treated with the antiviral drug lopinavir and ritonavir while in hospital. Such interactions were “carefully overlooked in the wake of the Covid-19 healthcare crisis,” the study’s authors concluded.

Pfizer said ritonavir has a well-characterized safety profile when used alone or in combination with other drugs. Although it can lead to drug interactions, it can be managed in many cases, it added.

For drugs that share a common pathway for drug metabolism as Pfizer’s oral antiviral drug, over the five-day treatment period, most patients will be able to adjust the dose of their medication, and then return to normal dosing. after completing the oral antiviral regimen, ”a Pfizer spokesman said.

The authorization and commercial performance of molnupiravir are important for Merck, which unlike Pfizer did not develop a Covid-19 vaccine. If the FDA authorizes emergency use for the drug, the U.S. government has a contract to buy 3.1 million courses for $ 2.2 billion.

Merck’s shares lost 17 percent of their value in the past month following the publication of data showing that Pfizer’s antiviral pill Paxlovid is more effective than molnupiravir in reducing the risk of hospitalization or death due to Covid.

UK and EU regulators granted emergency use or conditional authorization for treatment last month.

However, the authorizations were granted before Merck published final clinical trial data showing that the drug was 30 percent effective in reducing the risk of hospitalization and death in high-risk patients. This was sharply lower than the 50 percent efficiency that Merck announced in October from a preliminary analysis of the data.

Last week, Citi Merck downgraded from “buy” to “neutral”, noting the “clinical profile of” [molnupiravir] continues to deteriorate ”.

Barr at Merck said the safety profile of molnupiravir is “very strong” and many governments have expressed interest in acquiring supplies to combat Covid.

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