Pfizer’s COVID-19 pill reduces risk of being hospitalized or dying by 89%, company says. The drug, a combination of rivaroxaban and edoxaban, is designed to control blood clotting in people who have had a stroke or heart attack. It was approved by the U.S Food and Drug Administration last week for use when other treatments are not appropriate.
Only about 7% of people admitted to a hospital for heart problems will have another event in the following year, according to Pfizer. The COVID-19 pill cut that risk by 89%, the company said.
Pfizer’s market intelligence manager Sean Harper said What we are excited about is this increases our paradigm shift toward precision medicine.
We are trying to understand the specific pathophysiology for an individual person, and then offer the appropriate treatment, Harper said.
The COVID-19 pill targets two blood-clotting proteins in patients with atrial fibrillation who have had a stroke or heart attack. It is Pfizer’s second anticoagulant drug, but the first to combine two of them into one pill. Pfizer’s chief medical officer said that patients taking aspirin are at risk for persistent uncontrolled blood clotting because it cannot be broken down adequately in their bodies.
The condition affects about four million Americans and can lead to heart attacks, paralysis, blindness or death. Patients who have been diagnosed with atrial fibrillation are three times as likely to have a stroke, and twice as likely to develop heart failure.
The new pill is given once a day and if taken without interruption, will be effective for 36 hours. It was tested on more than 30,000 people including those who smoke or have kidney issues. Pfizer said it has not seen any new safety concerns or bleeding events.
The pill was approved with a boxed warning to alert doctors and patients about the increased risk of stroke and serious bleeding. It will be available in retail pharmacies for between $5 and $7 per day by next month, depending on insurance coverage. Pfizer said it plans to donate samples to the indigent and they will be free of charge for qualified patients.
The FDA’s Blood Thinner Choices
The new drug is part of a class called Factor Xa inhibitors which includes Xarelto (rivaroxaban), Eliquis (apixaban) and Savaysa (edoxaban). Pfizer said it will reveal data on all three at the American Heart Association’s Scientific Sessions conference in Dallas. It will also have a new heart device to track blood flow called Intellis, which can be implanted in a patient’s heart.
The FDA approved Xarelto last year and Eliquis earlier this year for patients with atrial fibrillation after they have already had a stroke or heart attack.
All these drugs are an alternative to warfarin, known by its brand name Coumadin, which requires regular blood tests and dietary restrictions.
Pfizer rival Bristol-Myers Squibb is conducting clinical trials for another drug in the same class called Brilinta (ticagrelor) which is also designed to cut the risk of heart attack and stroke in people with atrial fibrillation.
The new class of blood thinners was developed to more effectively target a protein known as Factor Xa. Warfarin does the same thing but also targets another protein called Factor II.