Major pharmaceutical companies are hoping to find the new blockbuster drug in a market now dominated by one of the oldest mainstay pills in medicine: the blood thinner warfarin, according to The Wall Street Journal (WSJ).
The WSJ said questions about the effectiveness and safety remain unanswered; however, the scope of the clinical and economic potential of the drugs are unlikely to emerge for at least two years. If clinical and regulatory hurdles are cleared, the global market for the blood thinners could exceed $10 billion by the middle of the next decade.
At a meeting of the American Society of Hematology in Atlanta, Johnson & Johnson (J &J) presented data that its experimental pill rivaroxaban is superior to Lovenox, an injectable treatment marketed by Sanofi-Aventis, in preventing clots in patients undergoing hip- or knee-replacement surgery, The WSJ reported. J &J is also co-developing rivaroxaban with Bayer, which discovered the compound.
Bristol-Myers Squibb (BMS), which is developing apixaban with Pfizer; Eli Lilly; Boehringer-Ingelheim; and Portola are all competing for the same market.
The WSJ said that the “big opportunity lies in treating atrial fibrillation,” an irregular heartbeat that afflicts an estimated 2.2 million Americans and 5.5 million people world-wide. The condition oftentimes leads to stroke, and patients need to be on daily therapy for the rest of their lives.
Warfarin, marketed by BMS as Coumadin, and generic versions of the drug is currently the most popular choice amongst doctors and patients. However, The WSJ said that doctors are concerned about what they call the “coagulation cascade, the system that causes clots to form to stop bleeding in the face of injury but can lead to heart attacks, strokes and clots.”
Four of the new blood thinners target an enzyme, factor Xa, one of the enzymes involved in the coagulation cascade.
Many of the major pharmaceutical companies are racing to complete and produce positive results of their drugs. J &J intends to file data from the three studies plus another nearing completion to the FDA by late next year, while Bayer has already filed for approval in Europe.