US FDA fast-tracks approval for Wockhardt drugs

Drugs were granted 5-years extension to the drug patents in the US

Mumbai-based Wockhardt Ltd has received Qualified Infectious Disease Product (QIDP) status from the US Food and Drug Administration (FDA) for two of its drugs, WCK 771 and WCK 2349. WCK 771 is an intravenous (IV) drug while WCK 2349 is a solid oral tablet, under anti-infective category. The drugs were also granted five-year extension to the drug patents in the US.

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.

A company statement said, “Both WCK 771 and WCK 2349 act against one of the globally rising class of pathogens, Methicillin-resistant Staphylococcus Aureus (MRSA) which causes a range of diseases from skin infections to severe respiratory infections. In case of severe infections like Hospital Acquired Pneumonia (HAP), current medical cure has a very limited reach causing a high unmet need and mortality. Both of these drugs are effective against MRSA and have shown potential in treatment of HAP.”

Habil Khorakiwala, chairman and CEO, Wockhardt Ltd, said, “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 -3 clinical trials early next year.”