The stock of drug maker >Wockhardt gained about 4 per cent in trade on Monday, after the US drug regulator – Food and Drug Administration (FDA) agreed to fast-track the approval for two of its innovative anti-infective drugs.

The two novel molecules WCK 771 and WCK 2349 have been granted the Qualified Infectious Disease Product (QIDP) status by the US FDA; which will not only mean faster approval for these two drugs thereby enabling early launch, but also extension of patent on these drugs by five more years. This is the first time that an Indian company has been given this status.

The US FDA grants QIDP status to drugs which cater to unmet medical needs, as identified by the Centre for Disease Control, USA.

The two molecules – WCK 771 and WCK 2349 target a rising class of pathogens called MRSA (Methicillin-resistant Staphylococcus Aureus). This pathogen is responsible for wide range of diseases in human beings right from minor skin infections to severe respiratory infection and hospital acquired pneumonia condition.

WCK 771 is an injectible drug while WCK 2349 is a solid oral tablet. Wockhardt is expected to commence global phase III trials on these two drugs by early next year.

Though the benefit from this may not accrue in the short-term, this has spelt some relief for the stock which was hammered following regulatory action on three of its plants.

Wockhardt’s Waluj and Chikalthana plant were banned from supplying to the US in 2013. In May 2014, its Chicago-based plant received observations in form 483 after the drug regulator found the company to be using questionable drug-testing procedures during an inspection conducted early this year.

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