USFDA grants QIDP status to two Wockhardt drugs

Written by PTI | New Delhi | Updated: Sep 1 2014, 01:03am hrs
WockhardtThis is the first instance of an Indian pharmaceutical company receiving QIDP status, said Wockhardt. (Reuters)
Drug maker Wockhardt today said that two of its anti-infective drugs have received Qualified Infectious Disease Product (QIDP) status from the US health regulator.

Two drugs, WCK 771 and WCK 2349, have received QIDP status, which allows fast-track review of the drug application by the US Food and Drug Administration (USFDA), Wockhardt said in a statement.

This is the first instance of an Indian pharmaceutical company receiving QIDP status, it added.

Commenting on the development, Wockhardt Founder Chairman and Group CEO Dr Habil Khorakiwala 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 USA, which is a major support for the commercial aspect of the drug."

These drugs will be entering their global Phase-3 clinical trials early next year, he added.

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, USA, a top US government health and safety body.

WCK 771 is an intravenous (IV) drug while WCK 2349 is a solid oral tablet.

Both act against Methicillin-resistant Staphylococcus Aureus (MRSA), which causes a range of diseases from skin infection 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," it added.