Morning Briefing
Summaries of health policy coverage from major news organizations
Pfizer Requests Approval For Antiviral Covid Pill
The New York Times: Pfizer Asks The F.D.A. To Authorize Its Covid Antiviral Pill
Pfizer has applied to the Food and Drug Administration to authorize its antiviral pill to treat unvaccinated people with Covid-19 who are at high risk of becoming severely ill, the company said on Tuesday. The drug, which will be sold under the brand name Paxlovid, could become available within weeks if authorization is granted. It is meant to be dispensed by pharmacies and taken at home. Paxlovid is the second antiviral pill to show effectiveness against Covid, in a new class of treatments for the disease that are expected to reach far more patients than other drugs that are typically given by infusion. (Robbins, 11/16)
The Wall Street Journal: Pfizer Submits Covid-19 Pill For FDA Authorization
“There is an urgent need for lifesaving treatment options,” Pfizer Chief Executive Albert Bourla said Thursday. “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. GILD -0.46% antiviral, remdesivir, is mostly used to treat hospitalized patients, while monoclonal antibody treatments have proven effective but are costly and typically given in doctor’s offices or hospitals. (Hopkins, 11/16)
The Biden administration has plans to buy many doses —
The Washington Post: Biden Administration To Buy Pfizer Antiviral Pills For 10 Million People, Hoping To Transform Pandemic
The Biden administration is planning to purchase 10 million courses of Pfizer’s covid pill, a $5 billion investment in a treatment that officials think will help change the trajectory of the coronavirus pandemic by reducing severe illness and deaths, according to two people with knowledge of the transaction. As the administration and Pfizer on Tuesday hammered out the final details, the company asked federal regulators to authorize the five-day antiviral pill regimen called Paxlovid. The medication is the second easy-to-take treatment aimed at keeping newly infected people out of the hospital to go before the Food and Drug Administration. The other is by Merck and Ridgeback Biotherapeutics. (Pager, McGinley, Johnson, Taylor and Parker, 11/16)
The New York Times: U.S. To Buy Enough Of Pfizer’s Covid Antiviral Pills For 10 Million People
The Biden administration plans to pay more than $5 billion for a stockpile of Pfizer’s new Covid-19 pill, enough for about 10 million courses of treatment to be delivered in the next 10 months, according to people familiar with the agreement. Senior federal health officials are counting on the drug to be a powerful weapon against Covid. When given promptly to trial groups of high-risk unvaccinated people who developed symptoms of the disease, the drug sharply reduced the risk of hospitalization and death. (LaFraniere and Robbins, 11/16)
Also —
Axios: Pfizer Agrees To Share Recipe For COVID-19 Pill
Pfizer has agreed to a licensing deal with the UN's Medicines Patent Pool for its COVID-19 pill — roughly a month after Merck said it licensed its COVID pill with the MPP. These antiviral pills have showed promising results in reducing the severity of infection and preventing death among the unvaccinated, and Pfizer's licensing agreement, combined with Merck's, will allow generic drug companies to cheaply produce the pills for more than 100 low- and middle-income countries. (Herman, 11/16)
Stat: Like Merck, Pfizer Strikes A Licensing Deal With The Medicines Patents Pool
Amid considerable anticipation over its Covid-19 pill, Pfizer (PFE) reached a licensing agreement with the Medicines Patent Pool, which in turn can now strike deals with other manufacturers to provide generic versions of the drug to 95 low and middle-income countries. The agreement follows a similar arrangement with Merck (MRK) concerning its own antiviral pill for combating the coronavirus. Notably, this also marks only the second time that a pharmaceutical company has struck a licensing deal with the Medicines Patent Pool — a public health organization backed by the United Nations — to widen access to a Covid-19 medical product. (Silverman, 11/16)
