European regulators opinion favors Arginox drug

The Committee for Orphan Medical Products, a division of the European Medicines Agency (EMEA), recommended the designation for Tilarginine Acetate Injection (TAI) for the treatment of cardiogenic shock. This favorable opinion requires final ratification by the European Commission.

If finalized, the designation will result in reduced marketing authorization fees, free access to scientific advice from the EMEA, and other potential research and development incentives. There is also the prospect of 10-years of market exclusivity if TAI reaches the market before its competitors. TAI has already been granted orphan drug status in the US, conferring similar privileges.

Cardiogenic shock (CS) is one of the most serious complications of a heart attack. Despite major advances in acute cardiac care that have led to dramatic improvements in heart attack survival overall, a similar benefit has not been realized for CS.

TAI is a first-in-class drug that inhibits the production of nitric oxide, a chemical normally found in many cells of the body. A growing body of research suggests that overproduction of nitric oxide following a heart attack may play a critical role in the development of CS. By blocking its production TAI has the potential to interrupt the cycle of circulatory shutdown that can quickly lead to death.

“We are committed to evaluating this novel therapeutic approach to the management of cardiogenic shock patients who have not had adequate treatment options to date, and we look forward to completing the enrollment of phase III with a large contribution from Europe,” said Dr Frans Van de Werf, chairman of the cardiology department of the University Hospital Gasthuisberg and member of the Global Steering Committee for the phase III trial evaluation of TAI.