Janssen Cilag PE drug receives approval

Janssen-Cilag’s Priligy (dapoxitine) drug has received approval in Finland and Sweden.

Used as an on-demand treatment for premature ejaculation (PE) in men aged between 18 and 64 years old, the oral medication has received endorsement following five phase III trials.

The company noted the product received a positive outcome in a decentralised marketing authorisation procedure – finalised in December last year – involving seven European countries – Austria, Finland, Germany, Italy, Portugal, Spain and Sweden.

Commenting on the approval, Dr Hartmut Porst from the Private Institute for Urology and Andrology in Hamburg, Germany said Priligy (dapoxitine) is an “important new medication” for patients and doctors.

He added: “The lack of a previously approved oral medication for PE has contributed to a substantial deficiency in the diagnosis and treatment of this common condition.”

Last year, Janssen-Cilag’s Doribax therapy received a recommendation from the European Authority for the treatment of nosocomial pneumonia and other related conditions.