Johnson & Johnson has submitted a New Drug Application to the US Food and Drug Administration for doripenem, an investigational carbapenem antibiotic for the treatment of complicated intra-abdominal and urinary tract infections.
The company said that doripenem, which is licensed from Japan's Shionogi, has demonstrated activity against a wide range of Gram-positive and Gram-negative bacteria including Pseudomonas, which is one of the leading causes of resistant hospital-acquired infections for which treatment options are limited.
J&J cited the Infectious Disease Society of America's figures which estimate that approximately two million people acquire bacterial infections in US hospitals each year and 90,000 people die as a result. If approved, doripenem will be marketed in the USA by J&J’s Ortho-McNeil unit.
CHMP positive on HIV drug Prezista
J&J also noted that its Tibotec subsidiary has received a positive opinion recommending conditional approval from Europe's Committee for Human Medicinal Products for its new HIV protease inhibitor Prezista (darunavir).
The proposed indication is for Prezista, co-administered with 100mg ritonavir, to be used in combination with other antiretrovirals in adults who failed more than one regimen containing a protease inhibitor. The drug received approval in the USA at the end of June and is expected to go up against Boehringer Ingelheim's Aptivus (tipranavir).