BackWockhardt gets USFDA nod for abridged clinical trial for new antibiotic drug
The USFDA agreed to an abridged phase-III trial after evaluating the pre-clinical and phase-I clinical data establishing safety and efficacy of the drug, says Wockhardt
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Wockhardt Ltd said on Monday that the US Food and Drug Administration (FDA) had agreed to abridged phase-III clinical trials for its new antibiotic molecule, named WCK 5222.
The antibiotic will be used to treat serious hospital-acquired infections such as pneumonia and is expected to work against some bacteria that have developed resistance to existing drugs.
The FDA agreed to an abridged phase-III trial after evaluating the pre-clinical and phase-I clinical data establishing safety and efficacy of the drug, Wockhardt said in a stock exchange filing.
“Wockhardt expects global clinical launch of WCK 5222 during the year 2020-21," the company said.
Shares of the drug maker rose 7.5% on the news before ending up 6.3% at Rs765.75 on BSE on Monday. The benchmark Sensex closed 1% higher at 29,905.52 points.
In December 2015, the US drug regulator accorded qualified infectious disease product (QIDP) status to WCK 5222, which provides for fast-track clinical development and a review of the drug application by the US FDA for approval. It also grants five-year marketing exclusivity to the product after approval.
The QIDP status was granted to the drug because of its potential to meet the urgent need of addressing antimicrobial resistance.
Currently, more than 700,000 deaths globally can be attributed to antimicrobial resistance every year and if no effective drugs are developed, an estimated 10 million lives a year would be at risk due to drug-resistant infections by 2050, Wockhardt said citing a report by British economist Jim O’Neill, titled The Review on Antimicrobial Resistance.
Zidebactam, one of the constituents of the WCK 5222 molecule, has been discovered through Wockhardt’s indigenous research. The company has four other new antibiotic molecules in phase-II and phase-III clinical trials and all of them have received QIDP status from the US FDA.
The abridged clinical trial approval is a positive development for the company, which is grappling with quality compliance issues in manufacturing plants since 2013. Over the past one year, Wockhardt’s shares have declined more than 30%.
In March 2017, Wockhardt’s US unit Morton Grove Pharmaceuticals Inc. received a warning letter from the US FDA for violation of norms, while the company’s indirect subsidiary in the UK, CP Pharmaceuticals, received a warning letter for its Wrexham facility in November 2016.
The company’s formulations units at Chikalthana and Waluj in Maharashtra have been under the US FDA’s import alert since 2013, while its bulk drug plant at Ankleshwar in Gujarat was issued an import alert in August 2016.
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