Wockhardt Gets FDA QIDP For 2 Anti-Infective Drugs
Global pharmaceutical and biotech firm Wockhardt announced that it has received Qualified Infectious Disease Product (QIDP) status for two of its anti-infective drugs, WCK 771 and WCK 2349, from the U.S. Food and Drug Administration (FDA). This is the first time the FDA has awarded QIDP status to an Indian pharmaceutical company, reports Reuters.
WCK 771 is an intravenous (IV) drug, and WCK 2349 is a solid oral tablet designed to act against antibiotic-resistant strains of bacteria and pathogens. The two drugs are also intended to treat infections caused by highly resistant bacteria including methicillin-resistant Staphylococcus aureus (MRSA) and multidrug-resistant Gram-negative bacteria, which account for a significant portion of hospital-acquired infections.
Dr. Habil Khorakiwala, Wockhardt Founder and Chairman, said that worldwide, there is a felt need for new antibiotics in the face of rising antibiotic-resistant pathogens. These are divided in gram-positive and gram-negative categories, which the company has worked to address over the years of developing drugs. “These two drugs act against one of the globally rising class of pathogens MRSA (Methicillin-resistant Staphylococcus Aureus) which causes a range of diseases from the 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.”
QIDP status is awarded to drugs that work against pathogens which have a high degree of unmet treatment needs as identified by the U.S. Centre for Disease Control (CDC). The designation opens the door for fast track review of an investigational drug and grants a 5 year extension to its U.S. patent.
Wockhardt announced that the two drugs will enter global Phase III clinical trials in early 2015.
Earlier this year, the company reported that it is expanding its Oral Solid manufacturing facility in Morton Grove, Illinois, U.S. Wockhardt also added a new R&D lab plus laboratory space for Quality Control.