4. Zulresso

Sage Therapeutics Zulresso product image
(Sage Therapeutics)

Active ingredient: brexanolone 
Disease: postpartum depression 
Peak sales estimate: $370 million 
Approved: March 19, 2019
Company: Sage Therapeutics 

The scoop: Two weeks after an FDA panel recommended Zulresso for approval in a near-unanimous vote, the agency put off its decision on the drug so it could work on a risk evaluation and mitigation strategy (REMS). The reason? Zulresso is given in one 60-hour intravenous infusion, during which some patients lose consciousness—an issue that cannot be solved through labeling alone. In March, Zulresso became the first FDA-approved treatment for postpartum depression, but with a black-box warning—the FDA’s most serious—for loss of consciousness and extreme sedation. Sage doesn’t think the REMS will be a barrier to uptake, and the company is working with infusion centers to make the multiple-day infusion a positive experience for patients. — Amirah Al Idrus 

4. Zulresso

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