Medicure plans to file a supplemental new drug application (sNDA) for the high-dose bolus (HDB) dosing regimen of tirofiban HCl (Aggrastat). The company also announced that the FDA has granted its request for a waiver of the $979,400 application fee for the planned sNDA.
The planned sNDA submission is to request the addition of the Aggrastat HDB regimen (an initial bolus of 25 mcg/kg and then continued at 0.15 mcg/kg/min) to the approved prescribing information. The rationale for the Aggrastat HDB regimen is to attain therapeutic platelet inhibition more rapidly than the currently approved dosing regimen (an initial rate of 0.4 mcg/kg/min for 30 minutes and then continued at 0.1 mcg/kg/min), according to the Winnipeg, Manitoba-based company.
According to Medicure, the FDA’s division of cardiovascular and renal drug products has indicated its willingness to review and evaluate this label change request based substantially on published studies involving the Aggrastat HDB regimen. The efficacy and safety of the HDB regimen has been evaluated in more than 20 clinical studies involving more than 7,000 patients and is currently recommended by the American College of Cardiology Foundation/American Heart Association treatment guidelines.
In September 2010, the Aggrastat HDB regimen was approved in the European Union.
The company anticipates filing the sNDA before the end of calendar year, which will result in a Prescription Drug User Fee Act (PDUFA) action date for the Aggrastat HDB sNDA in the second half of 2013. Under PDUFA, the FDA aims to complete its review within 10 months from the receipt of an sNDA submission.
The U.S. Federal Food, Drug and Cosmetic Act stipulates that sponsors requesting a label change for a prescription drug must pay a user fee prior to consideration of the sNDA. As of October, the amount of the user fee for the sNDA submission is $979,400.
The company said it applied for and was successful in receiving a waiver of this application fee under the barrier-to-innovation provision of the act. Therefore it is not required to pay any user fee for applications submitted within the next 12 months.