STAT+: Pharmalittle: FDA OKs Sage drug for postpartum depression; major U.S. health systems to offer Alzheimer’s drug

Good morning, everyone, and welcome to another working week. We hope the weekend respite was invigorating and refreshing, because that oh-so familiar routine of online meetings, calls, and deadlines has predictably returned, But what can you do? The world, such as it is, continues to spin. So to cope, we are brewing cups of stimulation — our choice today is cinnamon hazelnut. Meanwhile, we have assembled another menu of tidbits for you to peruse, and we hope you have a smashing day and conquer the world. And of course, do keep in touch. …

The U.S. Food and Drug Administration approved a new, rapid-acting medicine made by Sage Therapeutics to treat postpartum depression, the first oral treatment for the condition, STAT writes. But the agency rejected an indication for major depression, a much larger potential market. Biogen will co-market the drug, which will be sold under the brand name Zurzuvae, and split U.S. profits equally. For Sage, the new medicine is an opportunity to have a blockbuster medication for the first time, but failing to secure approval for major depression more broadly might put that goal out of reach. Analysts noted major depression is a much larger market.

Five major U.S. health systems will offer Leqembi, a promising new Alzheimer’s treatment from Eisai and Biogen, after working out payment and administrative policies, and how to assess and monitor patients, most likely in the next month or two, Reuters reports. Leqembi, which won full U.S. regulatory approval last month, is the first treatment proven to slow progression for people in the earliest stages of Alzheimer’s. Neurologists at the Mayo Clinic in Minnesota, Northwestern Memorial in Chicago, and Cedars-Sinai in Los Angeles plan a roll out in the next few months. Cleveland Clinic and Utah’s Intermountain health system said they have not started offering it.

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