"Pfizer Inc. said it asked U.S. health regulators to authorize its oral Covid-19 drug for use in high-risk patients, putting the pill on a path that could make it available for people to take at home by the end of the year.
Clearance from the U.S. Food and Drug Administration would give patients and doctors an easy-to-use treatment to keep people out of the hospital early in the course of the disease.
"There is an urgent need for lifesaving treatment options," Pfizer Chief Executive Albert Bourla said. "We are moving as quickly as possible in our effort to get this potential treatment into the hands of patients."
Health authorities and doctors have struggled with only a handful of options for treating Covid-19 patients, especially shortly after infection. A Gilead Sciences Inc. antiviral, remdesivir, is mostly used to treat hospitalized patients, while monoclonal antibody treatments have proven effective but are costly and typically given in doctor offices or hospitals.
Initial supplies of Pfizer's pill would be limited. Pfizer projects it will manufacture more than 180,000 courses of treatment this year, and plans to increase production to at least 50 million courses next year.
President Biden has said the U.S. has secured supply of the Pfizer drug, called Paxlovid. A person familiar with the matter said the U.S. was working on a contract for 10 million courses of treatment.
Pfizer also said Tuesday that it was licensing out Paxlovid to the Medicines Patent Pool, a United Nations-backed nonprofit to expand access to the drug to people in 95 low- and middle-income countries, including in sub-Saharan Africa. MPP expects to work with at least a dozen generic drugmakers that will make supplies and thereby drive down prices for low- and middle-income countries, MPP Executive Director Charles Gore said.
Many health experts and government health officials have expressed concern that poor countries would have less access to the antivirals than rich countries, as has happened with Covid-19 vaccines.
"We want to make absolutely certain that there is enough supply," Mr. Gore said.
Next year's production of Pfizer's pill is unlikely to meet global demand, Mr. Gore said. As many as 150 million adults globally could need Paxlovid because of infections and exposure to people with the virus, Pfizer said this month on its earnings call.
Paxlovid reduced the risk of hospitalization or death in high-risk people in a late-stage study with mild to moderate Covid-19 by about 89% if they took the pill within three days of diagnosis, Pfizer said this month.
Pfizer said it would forgo royalties in low-income countries, including after the pandemic. It said it would also waive royalties for other countries covered by the agreement during the pandemic, but afterward it will get royalties worth 5% of sales to governments and 10% of sales to the private sector.
Researchers reported Paxlovid was found to be generally safe and well-tolerated, Pfizer said. Paxlovid was performing so well in the trial that Pfizer said it stopped enrolling subjects after discussions with the FDA. Drugmakers typically stop studies, after discussion with health regulators, if an experimental drug is found to be so effective that it would be unethical to continue the study including subjects who received a placebo.
If the medicine is authorized, people could take Pfizer's drug at home shortly after they first develop Covid-19 symptoms. A course of treatment consists of 30 pills over five days. Twice a day, patients would take two pills of Paxlovid and one pill of another antiviral called ritonavir.
Pfizer said it also has begun submitting data and other information related to authorizing Paxlovid for use in other countries, including the U.K., Australia and New Zealand.
Should the FDA give the green light, Paxlovid could become the second easy-to-use treatment available in the world. Another Covid-19 pill, molnupiravir from Merck & Co. and Ridgeback Biotherapeutics LP, is under review by the FDA and could be cleared for use in the U.S. before the end of the year. The U.K. authorized it this month.
Merck also has a licensing deal with MPP to expand manufacturing of molnupiravir and has separately licensed out production of molnupiravir to generic drugmakers in India including Dr. Reddy's Laboratories Ltd.
Paxlovid works differently from the Merck-Ridgeback pill and presents fewer safety concerns, according to some physicians and scientists. Merck has said it is confident in molnupiravir's safety profile.
Researchers designed Pfizer's pill to stop the coronavirus from spreading in people by blocking activity of a key enzyme, known as protease, that the virus needs to replicate. Drugs blocking protease have proven effective against HIV, the virus that causes AIDS.
Pfizer researchers identified the drug in-house last year. The company has said Paxlovid was found in laboratory testing to respond against variants, including the highly contagious Delta strain, but hasn't said how the drug fared against variants in the late-stage study of high-risk people." [1]
1. Pfizer Seeks Approval of Virus Pill --- FDA asked to authorize easy-to-use treatment as U.S. secures supply, licenses are granted
Hopkins, Jared S. Wall Street Journal, Eastern edition; New York, N.Y. [New York, N.Y]. 17 Nov 2021: A.1.
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