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 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 U.S. Food and Drug Administration approved Boston Scientific Corp.’s drug-coated stent Eluvia to treat narrowed arteries in the leg.
Netherlands-based health tech company Royal Philips will move its North American headquarters to Cambridge, Mass. from Andover, Mass. by 2020.
Amgen’s PSCK9 inhibitor Repatha continues to impress as a treatment for patients with peripheral artery disease (PAD) and a history of heart attacks. New data shows Repatha hit its primary endpoints and significantly reduced first-time cardiovascular events by 27 percent in PAD patients.
German drugmaker Bayer moved to tap a potentially lucrative new market opportunity for its blockbuster clot prevention drug Xarelto, requesting approval in Europe to make atherosclerosis patients eligible for treatment.
Bayer’s best-selling blood-thinning drug Xarelto has also proved effective in preventing heart attacks and strokes in patients suffering from certain types of artery disease.