Orexigen updates on obesity drug filing plans

US biopharma company Orexigen Therapeutics (Nasdaq: OREX) yesterday (August 7) announced its plan to submit a Marketing Authorization Application for its much delayed weight-loss product Contrave (naltrexone SR/bupropion SR) to the European Medicines Agency utilizing the centralized procedure.

Orexigen has met with the European rapporteurs to discuss the filing strategy of the MAA. Both were supportive of the company's plan to submit the application in advance of the Light Study interim analysis and to have cardiovascular outcomes data from the Light Study available for the Committee for Medicinal Products for Human Use (CHMP) Day 120 List of Questions.

"We are pleased with recent progress toward the Contrave MAA for Europe. From our interactions with multiple regulatory authorities in Europe, including with the assigned rapporteur and co-rapporteur, we believe European regulators recognize the need for new obesity therapeutics and support our plans for submission of the Contrave MAA," said Michael Narachi, chief executive of Orexigen.