Wockhardt Limited has announced that the US FDA has granted qualified infectious disease product (QIDP) status to their product WCK 5222, the fourth product from the company to be granted the designation. The other three products to receive QIDP status are WCK 711, WCK 2349 and WCK 4873.
There is a global crisis in the field of antibiotic research, due to ever rising levels of antibiotic resistance and a relative lack of novel antibiotics being discovered. QIDP status is granted to drugs identified by the Center for Disease Control (GA, USA) as acting against pathogens which have a high degree of unmet need in their treatment.
QIDP status provides fast-tracked clinical development and FDA review and a five-year extension of market exclusivity post-product approval in the US. It was created in 2012 as part of the FDA Safety and Innovation Act to promote urgently needed innovation in antibiotics development.
Habil Khorakiwala, chairman of Wockhardt Limited stated, “We are pleased that WCK 5222 has received the coveted QIDP status, a fourth for the company. WCK 5222 is a new class of antibiotic for gram negative terrain for complicated urinary tract infections and Hospital Acquired Bacterial Pneumonia (HABP)/VABP. We believe that when WCK 5222 is approved it will save many lives worldwide.”