India: Dr. Reddy's and US Announce Filing of NDA for Migraine Candidate

Dr. Reddy’s Laboratories Ltd. (DRL) and its US subsidiary, Promius Pharma, LLC have announced the filing of a New Drug Application (NDA) for its migraine candidate DFN-02 with the USFDA.

According to Dr. Anil Namboodiripad, Senior Vice President, Proprietary Products and President, Promius Pharma, the NDA for DFN-02 is an important step forward in the company’s mission to bring solutions that address unmet needs.

“The filing of DFN-02 NDA re-presents our continuing commitment to bring innovative solutions in migraine treatment,” he said. “Acute migraine attacks are typically associated with pain and symptoms, such as nausea, photophobia, and phonophobia. It is important that an effective migraine treatment helps address associated symptoms. Equally important is having a well-tolerated treatment that provides patients a satisfactory resolution of their migraine- attack.” In a multi-centre, double-blind, randomized, placebo controlled study with 107 subjects, DFN-02 has demonstrated that it can effectively treat pain and associated symptoms during a migraine attack and reduce attack-related functional disability. Data from this study show that there was a significantly higher proportion of subjects who experienced 2-hour pain freedom with DFN-02 compared with placebo. DF-N-02 was also significantly better thanplacebo at alleviating the patients’ most bothersome symptom (MBS), including nausea, photophobia, and phonophobia. The drug was also well tolerated.

Upon approval, the product will be commercialized by Promius Pharma.

Senior leadership change

Meanwhile, DRL has announced a change in the makeup of its senior leadership team. Following a 15-year career with the company, Mr. Abhijit Mukherjee, Chief Operating Officer, will retire on March 31, 2018. He will be succeeded by Mr. Erez Israeli, former President & CEO of Enzymotec.

Mr. Israeli will join as Chief Operating Officer and Global Head of Generics & PSAI, based out of Hyderabad. He will report to Dr. Reddy’s Co-Chairman & CEO, Mr. G.V. Prasad.