Orexigen Therapeutics and marketing partner Takeda will have to wait a bit longer before their weight-loss drug gets to market after regulators in the USA said they need more time to evaluate the firms’ resubmission.
There was much speculation as to whether the US Food and Drug Administration would decide on the fate of NB32 (naltrexone/bupropion), formerly known as Contrave this week. The agency rejected the drug in 2011 over a deficiency related to cardiovascular safety and demanded a major outcomes trial.
However, the FDA has extended its review for NB32 by three months, pushing back the Prescription Drug User Fee Act action date to September 11. The agency says the extension is needed to reach agreement on the post-marketing obligation related to the resubmission package which includes interim safety and CV outcomes data from an ongoing 8,900 patient study.
Discussions around the package insert and other matters are ongoing with the agency, said Orexigen chief executive Michael Narachi. He added that “we are encouraged by the high level of engagement with the FDA, and are confident that we can reach agreement on the remaining post-marketing obligation”.
If approved, NB32 will be the third obesity drug to get to the US market. However the launches of Vivus’ Qsymia (phentermine/topiramate) and Arena/Eisai’s Belviq (lorcaserin) have been underwhelming. Analysts believe Takeda’s marketing strength will be a major factor but news of the delay has unnerved investors and Orexigen shares took a bashing.
