Pfizer has proposed to the Food and Drug Administration to sell injections to adults to help prevent blood clots and strokes. It would use the approved use of a blood booster from another company, Cleviprex, as a case study for expanded use. The F.D.A. is reviewing Pfizer’s request to get an approval for “safety-related uses” of Cleviprex as a multipurpose medication for people over 40 years old.
Covid+Rex & Resput. is a dual capsule for the treatment of acute heart failure, total joint replacement, and myocardial infarction. It combines an anticoagulant (Covidopa®) with the blood thinning agent, glycoprotein C1, or BP-D1. Further, the FDA is considering whether to allow use of generics of Cleviprex in other countries.
The multinational pharmaceutical company proposed to use the approval of Cleviprex as a case study for the treatment of whole individuals with partial reversibility of acute myocardial infarction and all persons aged 40 years and older. Patients would need to take the Cleviprex booster shots at least every other week and would also need regular blood thinning.
While Covid+Rex & Resput. can manage some acute coronary syndromes, as intended by the manufacturer, there is growing evidence that vessylolecanons — a vessylone drug that blocks circulation — can also reduce interventital blood flow. Studies show that vessylone works by binding to the thrombin receptor and preventing thrombin synthesis, and the FDA has not approved or allowed the use of vessylone in the U.S. to prevent thrombin supply. In certain cases, it has been shown that vessylone has improved the outcomes of major bleeds following an acute myocardial infarction.
Pfizer hopes that using Cleviprex will expand its market and lead to up to $1 billion of sales by 2030. The prescription drug, which Pfizer has been using with a human trial, was launched in the U.S. in 2017. The use of Covid+Rex & Resput. in patients over 40 already has the endorsement of the European Medicine Agency (EMA) and the European Food Safety Authority (EFSA). However, the FDA’s approval of the product would be a significant step toward expanding its market to other populations.