CroFab™ for pit viper envenomation
CroFab™ fact sheet
CroFab™ [Crotalidae Polyvalent Immune Fab (Ovine)] is a treatment for mild or moderate envenomation from North American Crotalid snakes (pit vipers, including rattlesnakes), which was granted FDA approval on 2 October 2000. CroFab™ was the first new product entry into the American antivenom market in over 50 years, and rapidly established itself as the market leader. Today, CroFab™ is the only product to be actively marketed in the US, where it is sold through Fougera Inc, a division of Altana Inc, our distribution partner.
It is estimated that there are around 8,000 venomous snakebites in the US each year, creating a market potential of up to US$70-80 million per annum based on an assumed average treatment cost of US$10 000 per patient. There are 10-15 deaths each year, underlining the need for prompt and adequate treatment. For more information on snakebites in the US visit http://www.snakebitenews.com
CroFab™ has an excellent safety profile and the product has been extremely well received by physicians. This has encouraged doctors to treat more bite victims, including patients with milder bites, as well as to start treatment with CroFab™ earlier in the course of poisoning to reduce its severity.
Marketing efforts are currently focused on expanding the CroFab™ market to include the more widespread treatment of milder pit viper bites, such as those caused by Copperheads. While the majority of rattlesnake bites occur in the Western states, Copperheads are found mostly in the Eastern states and account for nearly 40% of pit viper snake bites (including rattlesnakes) in the US. Although seldom fatal, these bites can be serious, and victims can often be incapacitated for several months.
The most common adverse events reported in clinical studies were mild or moderate reactions involving the skin and appendages (primarily urticaria, rash or pruritus), which occurred in 14 out of 42 patients. Two patients experienced severe allergic reactions (severe hives and a severe rash and pruritus) following treatment. One patient experienced recurrent coagulopathy due to envenomation which required rehospitalisation and additional antivenin administration. In clinical trials, recurrent coagulopathy (the return of a coagulation abnormality after it has been successfully treated with antivenin), characterised by decreased fibrinogen, decreased platelets and elevated prothrombin time, occurred in approximately half of the patients studied. Recurrent coagulopathy may persist for 1 to 2 weeks or more. One patient discontinued CroFab™ therapy due to an allergic reaction. Patients with allergies to papain, chymopapain, other papaya extracts or the pineapple enzyme bromelain may also be at risk for an allergic reaction to CroFab™.
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