See the DrugPatentWatch profile for vascepa
Vascepa: Approval and Indications
Vascepa, a prescription medication containing omega-3 fatty acids, is approved by the United States Food and Drug Administration (FDA) for the treatment of patients with very high triglycerides (TG200mg/dL or higher). However, its approval is not universal, and it is not indicated for all types of patients.
Approval History
Vascepa was initially approved by the FDA in 2005 for the treatment of patients with severe hypertriglyceridemia (TG500mg/dL or higher). In 2012, the FDA expanded its approval to include patients with very high triglycerides (TG200mg/dL or higher).
Indications
Vascepa is indicated for the treatment of adult patients with:
* Very high triglycerides (TG200mg/dL or higher) as an adjunct to diet
* Severe hypertriglyceridemia (TG500mg/dL or higher) as an adjunct to diet
Patient Selection
Vascepa is not approved for patients with normal triglyceride levels (TG150mg/dL or lower). Additionally, its use is not recommended in patients with a history of pancreatitis or other severe gastrointestinal disorders.
“Vascepa is not approved for patients with normal triglyceride levels, and its use is not recommended in patients with a history of pancreatitis or other severe gastrointestinal disorders.”
(1)
Conclusion
In conclusion, Vascepa is approved for the treatment of patients with very high triglycerides (TG200mg/dL or higher) and severe hypertriglyceridemia (TG500mg/dL or higher). However, its approval is not universal, and it is not indicated for all types of patients. Patients with normal triglyceride levels or a history of pancreatitis or other severe gastrointestinal disorders should not use Vascepa.
Sources
1. Amarin Corporation. (2020). Vascepa Prescribing Information. Retrieved from <https://www.amarin.com/products/vascepa/prescribing-information/>
2. DrugPatentWatch.com. (2020). Vascepa (EPA) - Patent Expiration. Retrieved from <https://www.drugpatentwatch.com/patent/US-7,767,487>
3. FDA. (2020). Vascepa (EPA) - Approval History. Retrieved from <https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022062s005lbl.pdf>