The U.S. Food and Drug Administration approved an expanded peripheral artery disease indication for Janssen’s Xarelto (rivaroxaban) vascular dose (2.5 mg twice daily plus aspirin 100 mg once daily) to include patients following recent lower-extremity revascularization due to symptomatic PAD.
The Janssen Pharmaceutical Companies of Johnson & Johnson presented data from the Phase 3 VOYAGER PAD study which showed Xarelto (rivaroxaban) (2.5 mg twice daily) in combination with aspirin (100 mg once daily) consistently reduced severe vascular events in patients with peripheral artery disease (PAD) after lower-extremity revascularization compared to aspirin alone regardless of whether it was the first, second, third or subsequent event.
The U.S. Food and Drug Administration approved AstraZeneca Plc’ drug for reducing the risk of a first heart attack or stroke in high-risk patients with coronary artery disease.
The Janssen Pharmaceutical Companies of Johnson & Johnson announced the VOYAGER PAD study met its primary efficacy and principal safety endpoints.
Orchestra BioMed Inc., in partnership with Terumo Corporation, announced Breakthrough Device Designation was granted by the U.S. Food and Drug Administration for the biomedical innovation company’s Virtue Sirolimus-Eluting Balloon in the treatment of below-the-knee peripheral artery disease.
The FDA approved Gadavist for use in cardiac magnetic resonance imaging to assess myocardial perfusion and late gadolinium enhancement in adults with known or suspected CAD.
Privately held Azurity Pharmaceuticals won approval for a liquid form of a hypertension drug for both adult and pediatric patients.