NEW YORK (VINnews) — Israel recently spent 30 million NIS to purchase a supply of Regeneron, a drug designed to prevent deterioration in the condition of coronavirus patients. The drug, which was successfully used by Donald Trump when he suffered a bout of coronavirus last fall, has been approved for emergency use by the U.S. Food and Drug Administration following impressive results in initial clinical trials.
Officials hope the drug, aside from saving lives and preventing suffering, will also help reduce the number of patients in serious condition, thereby keeping the country’s hospitals from collapsing and allowing the economy to remain open. However the drug, which is administered intravenously, is only effective if given in the first few days after infection, before the case has become serious. Moreover the price tag of the drug is prohibitive. Israel purchased just 2,500 doses of the drug at $1600 per dose and the price will double for every dose purchased afterwards. Thus it will only be used in specific cases of people at high risk of serious illness and infection, primarily those who are unvaccinated.
At the same time, pharmaceutical giant Merck in conjunction with Ridgeback Biotherapeutics announced Friday that they have developed an oral drug which reduces the risk of hospitalization or death by around 50% for patients with mild or moderate cases of Covid. The companies plan to seek emergency authorization for the antiviral Covid treatment after the medicine showed “compelling results” in clinical trials. Recruitment for the trials stopped early due to the positive results shown in initial trials.
The drug, molnupiravir, works by inhibiting the replication of the coronavirus inside the body. Interim results showed that 7.3% of the 775 coronavirus patients who were treated with molnupiravir were hospitalized within 29 days. Of the patients who received a placebo, 14.1% were hospitalized or died by day 29. No deaths were reported in patients who were given molnupiravir within the 29-day period, while eight deaths were reported in placebo-treated patients.
The participants in the trial were all at high risk. All were unvaccinated and each one had another risk factor, such as obesity, heart disease, diabetes or being over age 60. Results of the trial demonstrated that the drug worked irrespective of the timing of symptom onset and was effective in treating all variants of Covid, including the widely dominant and highly transmissible delta strain.
White House chief medical advisor Dr. Anthony Fauci expressed cautious optimism about the new drug, stating Friday that “The FDA will look at the data and in their usual, very efficient and effective way, will examine the data as quickly as they possibly can, and then it will be taken from there,” Fauci said.
Merck is currently testing molnupiravir in a separate global phase 3 study to evaluate its efficacy in preventing the spread of Covid within households.
Ridgeback Biotherapeutics CEO Wendy Holman announced Friday that “With the virus continuing to circulate widely, and because therapeutic options currently available are infused or require access to a healthcare facility, antiviral treatments that can be taken at home to keep people with Covid-19 out of the hospital are critically needed.”
“We are very encouraged by the results from the interim analysis and hope molnupiravir, if authorized for use, can make a profound impact in controlling the pandemic,” she said.
Merck said Friday it plans to seek emergency use authorization for the drug in the U.S. as soon as possible. The company also plans to submit marketing applications to other international drug regulators. If authorized by regulatory bodies, molnupiravir could be the first oral antiviral medicine used against Covid.
Merck has entered supply and purchase agreements for the drug with other governments — pending regulatory authorization — and is in discussions with other governments about the supply of molnupiravir.
The company said it plans to implement a tiered pricing approach based on World Bank country income criteria to ensure molnupiravir can be accessed globally. Merck previously announced that it had entered into nonexclusive voluntary licensing agreements for molnupiravir with generic manufacturers, a move intended to assist low and middle-income countries in gaining access to the treatment. Those agreements are also pending approvals or emergency authorization by local regulators.