Wockhardt’s New Drug Discovery programme in anti-infective research received a major boost after two of its drugs, WCK 771 and WCK 2349, received the coveted Qualified Infectious Disease Product (QIDP) status from the US FDA.
A QIDP status is granted to drugs which act against pathogens which have a high degree of unmet need in their treatment and are identified by the Centre for Disease Control, US, a top US government health and safety body. QIDP status allows for fast track review of the drug application by US FDA paving way for an early launch.
Commenting on the achievement, Dr Habil Khorakiwala, Founder Chairman and Group Chief Executive Officer, Wockhardt, said, “This is indeed a proud moment for us. Not only does the status allow for fast track review of our drug application, it also grants a five-year extension to the drug patents in the US which is a major support for the commercial aspect of the drug. These drugs will be entering in their global phase-III clinical trials early next year.”
WCK 771 is an intravenous (IV) drug while WCK 2349 is a solid oral tablet, which is a significant positive for the drug development scenario as currently there is very little advance drug research in developing solid oral dosages. Most of the research is in developing intravenous drugs.
EP News Bureau – Mumbai
