Sun Pharma’s Deuruxolitinib IND Placed on Partial Clinical Hold
The agency decision follows the report of a serious adverse event of pulmonary embolism occurring at the 12 mg twice a day dose in one of the long-term open label extension studies.
Despite the serious adverse event, the company said that no thromboembolic events occurred in phase 2 and phase 3 clinical trials and that it will work with the FDA to address the agency’s concerns, which will be expressed in a formal letter, to be received by Sun Pharma within the next 30 days.
About Sun Pharmaceutical Industries Limited
Sun Pharmaceutical Industries Limited (Sun Pharma) is an Indian multinational pharmaceutical company headquartered in Mumbai, that manufactures and sells pharmaceutical formulations and active pharmaceutical ingredients (APIs) in more than 100 countries across the globe. It is the largest pharmaceutical company in India and the fourth largest specialty generic pharmaceutical company in the world. The products cater to a vast range of therapeutic segments covering psychiatry, anti-infectives, neurology, cardiology, diabetology, gastroenterology, ophthalmology, nephrology, urology, dermatology, gynaecology, respiratory, oncology, dental and nutritionals. Its active pharmaceutical products include baricitinib, brivaracetam, and dapaglifozin.
May 4, 2023