预约演示

Side effects appear to have thwarted FDA approval of Biogen, Sage's Zurzuvae in MDD

2023-09-04

上市批准临床结果临床研究

Newly-released documents from the FDA reveal the agency's safety concerns that led to the rejection of Biogen and Sage Therapeutics' application for Zurzuvae (zuranolone) in major depressive disorder (MDD). The regulator's review highlighted a signal for suicidal ideation and behaviour that was seen in MDD studies, but not in those for postpartum depression (PPD).

The FDA approved the oral GABAA receptor positive allosteric modulator for PPD in adults last month, but denied its authorisation in the larger indication of MDD. Since the agency's split decision, Sage has been forced to undertake cost-cutting measures, including slashing 40% of its workforce, as it attempts to capitalise on the US launch of Zurzuvae for PPD in the fourth quarter.

RBC Capital Markets analyst Brian Abrahams, who reviewed the new FDA documents, noted that one patient with MDD was unresponsive to stimuli for 50 minutes after receiving a high dose of Zurzuvae. That patient, given a dosage 30% to 50% higher than what is now approved, also lost consciousness twice, while another subject lost consciousness for nearly five hours.

No signal in PPD

The FDA noted "there was no signal for suicidal ideation and behaviour in the PPD studies… However, because there was a signal in the MDD studies, and we cannot rule out an effect, we will include suicidal thought and behaviour warning language" in any potential label in this indication. Commenting on the safety issues, Sage spokesman Matthew Henson said that they involved patients given the oral solution of Zurzuvae, rather than the approved capsule formulation.

"It is inaccurate and misleading to extrapolate findings associated with the oral solution to the PPD population," Henson noted, adding that there were no reports of loss of consciousness in any of the participants in the PPD and MDD studies given the capsule version of Zurzuvae.

Abrahams estimates that the drug will generate annual sales of $240 million in PPD, but he's not hopeful of approval in MDD, where its use would likely be chronic. In PPD, the analyst noted that the "FDA seemed comfortable (with effectiveness) and durability were rapid and clinically meaningful, and had slightly fewer concerns on safety given likelihood of one-time use and lower possible suicidality risk."

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