FDA News: Weekly Review… June 28th
APPROVED! KENGREAL (cangrelor) an intravenous antiplatelet drug that prevents formation of harmful blood clots in the coronary arteries, the blood vessels that supply blood to the heart. (The Medicines Company, Parsipanny, NJ, Approved 6/22/15)
Indication : Adjunct to percutaneous coronary intervention (PCI) to reduce the risk of periprocedural myocardial infarction (MI), repeat coronary revascularization, and stent thrombosis (ST) in patients who have not been treated with a P2Y12 platelet inhibitor and are not being given a glycoprotein IIb/IIIa inhibitor
- CHAMPION PHOENIX Trial – Primary outcome measure of first occurrence of any one of the composite endpoint of all-cause mortality, myocardial infarction, ischemia-driven revascularization, and stent thrombosis within 48 hours after randomization. Kangreal vs Clopidogrel (p<0.005)
- Two additional trials, CHAMPION PCI and CHAMPION PLATFORM were terminated early for futility
- Higher Bleeding – all categories – with Kangreal vs clopidogrel.
- Higher rate of discontinuation for bleeding higher with Kangreal.
Positioning: While Kengreal provides another treatment option for patients – it requires intravenous administration and causes increased bleeding vs clopidogrel, an orally administered antiplatelet that is generic. Innovative Payor strategy will be important to effectively differentiate the drug.
Post-Marketing Safety Assessments and Label Updates:
- POTIGA (ezogabine, GlaxoSmithKline): Risks of vision loss adequately managed by approved labeling. No updates to Labeling (Boxed Warning) and approved REMS. Long-term observational study required. Skin discoloration is a cosmetic effect. http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm452049.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery
- DAYTRANA PATCH (methylphenidate transdermal system, Noven Pharmaceuticals, Inc.,): Permanent loss of skin color may occur – chemical leukoderma. Labeling updated to include Warning. http://www.fda.gov/Drugs/DrugSafety/ucm452244.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery
- XELIJANZ (tofacitinib, Pfizer): Increased risk of herpes zoster in Japanese patients. Updates to labeling and REMS.http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=IndvRemsDetails.page&REMS=69
Analysis : Effective Pharmacovigilance and Signal Detection (FDA and Sponsor initiated) critical for benefit/risk assessment and appropriate labeling for marketed products. Highlights the importance of use of the MedWatch program by patients and health care professionals.