Brilique (ticagrelor) new formulation gains European approval

Posted: 25 May 2017 | | No comments yet

The European Commission has granted marketing authorisation for AstraZeneca’s Brilique (ticagrelor) orodispersible tablets (ODT) as a new formulation…

The European Commission (EC) has granted marketing authorisation for AstraZeneca’s Brilique (ticagrelor) orodispersible tablets (ODT) as a new method of treatment administration.

This decision means that ticagrelor will become the first and only P2Y12 receptor inhibitor to be made available in ODT form in Europe.

Difficulty swallowing tablets

The new formulation of ticagrelor is designed for patients requiring anti-platelet therapy, but who are either intubated or have difficulty swallowing film coated tablets. This method of treatment administration allows interventional cardiologists, emergency staff and ambulance teams to ensure patients receive the appropriate treatment immediately.

Professor Gilles Montalescot, Head of the Cardiac Care Unit at Pitié-Salpétrière Hospital, Paris, said: “This approval for the new ODT formulation of ticagrelor is extremely welcome news. Having an ODT formulation means we can help address the needs of patients who aren’t able to swallow pills and bring rapid administration when required. It will provide healthcare professionals with greater flexibility in delivering the required treatment and meeting their patient’s needs.”

New formulation

Ticagrelor 90mg ODT is administered by placing the tablet on the tongue where it is rapidly dispersed in saliva. It can then be swallowed with or without water. The tablet can also be dispersed in water and administered via a nasogastric tube (CH8 or greater). Patients will be able to use ticagrelor 90mg ODT as an alternative to ticagrelor 90mg film-coated tablet if they are intubated or have difficulty swallowing film-coated tablets.

Elisabeth Björk, Vice President, Head of Cardiovascular and Metabolic Diseases, Global Medicines Development, AstraZeneca, said:

“We are excited to be able to provide patients with a new treatment option that will allow greater flexibility in administration, and present healthcare professionals with a further mechanism for delivering high quality care.”

“Cardiovascular diseases continue to be a leading cause of death in Europe and we are committed to ensuring new treatment options are developed to meet the range of patient needs.”

Approval worldwide

The approval grants marketing rights in 28 member countries of the European Union (EU) countries plus Iceland, Norway and Liechtenstein.