Products

Date: 2018-10-12

Type of information: Granting of a Market Authorisation in the US

Product name: Xarelto®

Compound: rivaroxaban

Therapeutic area: Cardiovascular diseases

Action mechanism: anticoagulant agent/oral direct Factor Xa inhibitor

Company: Bayer Healthcare (Germany) Janssen Research & Development, a J&J company (USA - NJ)

Disease:

• prevention of atherothrombotic events in adult patients with coronary artery disease (CAD) or symptomatic peripheral artery disease (PAD) at high risk of ischaemic event

Latest news:

• • On October 12, 2018, the FDA has approved rivaroxaban (Xarelto®), 2.5 mg twice daily, plus aspirin low dose once daily to reduce the risk of major cardiovascular events including cardiovascular (CV) death, heart attack or stroke in patients with chronic coronary artery disease (CAD) or peripheral artery disease (PAD).
• The FDA approval is based on data from the Phase III COMPASS study, which showed that rivaroxaban vascular dose, 2.5 mg twice daily, plus aspirin 100 mg once daily reduced the risk of the composite of stroke, CV death and heart attack by 24% (relative risk reduction) compared with aspirin 100 mg once daily alone in patients with CAD or PAD.
• • On August 23, 2018, the European Commission has approved a regimen of Xarelto® (rivaroxaban) 2.5 mg twice daily plus acetylsalicylic acid (ASA) 75-100 mg once daily for the prevention of atherothrombotic events in adult patients with coronary artery disease (CAD) or symptomatic peripheral artery disease (PAD) at high risk for ischemic events. The first country where Xarelto® is planned to become available for these patients is Germany.
• The EU approval is based on data from the Phase III COMPASS study, which showed that rivaroxaban vascular dose, 2.5 mg twice daily, plus ASA 100 mg once daily reduced the risk of the composite of stroke, cardiovascular death and heart attack by 24% (relative risk reduction) compared with ASA 100 mg once daily alone in patients with CAD or PAD.
• Data from the COMPASS study are also currently under review by regulatory authorities globally, and notably by the U.S. Food and Drug Administration (FDA) where it is part of a supplemental New Drug Application (sNDA).
• • On 26 July 2018, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for Xarelto®. The CHMP adopted a new indication for Xarelto® 2.5 mg tablets as follows:
• -“Xarelto®, co-administered with acetylsalicylic acid (ASA), is indicated for the prevention of atherothrombotic events in adult patients with coronary artery disease (CAD) or symptomatic peripheral artery disease (PAD) at high risk of ischaemic events.” The full indications for Xarelto 2.5 mg tablets will be as follows:
• - Xarelto®, co-administered with acetylsalicylic acid (ASA) alone or with ASA plus clopidogrel or ticlopidine, is indicated for the prevention of atherothrombotic events in adult patients after an acute coronary syndrome (ACS) with elevated cardiac biomarkers.
• -Xarelto®, co-administered with acetylsalicylic acid (ASA), is indicated for the prevention of atherothrombotic events in adult patients with coronary artery disease (CAD) or symptomatic peripheral artery disease (PAD) at high risk of ischaemic events.
• • On December 11, 2017, Bayer´s development partner, Janssen Research & Development, has submitted a supplemental New Drug Application (sNDA) to the FDA for the rivaroxaban (Xarelto®) vascular dose, 2.5 mg twice daily, to be used in combination with low dose aspirin. The application requests approval of two new indications for the rivaroxaban vascular dose: for reducing the risk of major cardiovascular (CV) events such as CV death, heart attack or stroke in patients with chronic coronary and/or peripheral artery disease (CAD/PAD), and for reducing the risk of acute limb ischemia in patients with PAD. This application is based on the Phase III COMPASS study.

Patents:

Submission of marketing authorization application USA : 2017-12-11

Submission of marketing authorization application UE:

Withdrawal of marketing authorization application USA:

Withdrawal of marketing authorization application UE:

US authorization: 2018-10-12

UE authorization: 2018-08-23

Favourable opinion UE: 2018-07-26

Favourable opinion USA:

Orphan status USA:

Orphan status UE:

Pediatric exclusivit _USA:

Pediatric exclusivity UE:

OTC status:

Other news:

Is general: Yes