Editors' (re)View: PPD approval worth celebrating; Novo pads obesity pipeline

Aug. 11, 2023
Pharma Manufacturing editors Karen Langhauser and Andrea Corona comment on the notable happenings in the pharma industry from the week of August 7.

Editor’s note: Welcome to Editors' (re)View, our editors’ takes on things going on in the pharma world that deserve some extra consideration.

Postpartum depression drug worth celebrating 

Earlier this week, we reported that the FDA signed off on the first oral drug designed to treat postpartum depression (PPD) in adults, branded Zurzuvae. 

Developed by Biogen and Sage Therapeutics, the treatment is a neuroactive steroid (NAS) GABA-A receptor positive allosteric modulator. Despite being the first of its kind to gain approval, the drug was turned down as a treatment for major depressive disorder — the much larger indication — causing Sage's shares to plummet to a record low after the announcement. 

But the drug’s greenlight for PPD is still a win worth nothing for Sage and Biogen. 

While exact PPD statistics are hard to pin, recent studies have shown that 1 in 7 women are susceptible to PDD within the year after giving birth. Every year, there are around 4 million births in the U.S., which means there are approximately 600,000 PDD patients who had no specific treatment option until Sage’s Zulresso, an intravenous injection treatment for PPD  was approved in 2019. 

Now offering a less invasive option for patients, Zurzuvae, which is taken orally once-daily for 14 days, ventures into a novel area of oral solid dose development, which involves the reformulation of injectable drugs to oral forms of medication. 

So for patient populations with unmet needs and for the future of OSD, Zurzuvae is a step in a hopeful direction. 

— Andrea Corona 

Novo pads obesity pipeline

This week, we reported that Novo Nordisk agreed to acquire Montreal-based Inversago Pharma in a deal that could end up being worth $1.075 billion.

And yes, I’m writing about weight loss drugs again (can you guess what my next cover story is about?) — but this deal is particularly interesting because Inversago focuses on CB1 receptor-based therapies, which are different from Novo’s current market-leading approach, focused on GLP1 agonists.

Inversago’s oral candidates block the cannabinoid CB1 receptor, which plays an important role in metabolism and appetite regulation. Back in 2006, Sanofi had an antiobesity CB1 blocker, rimonabant, approved in Europe, but an FDA AdComm shot it down, citing psychiatric disorders, including depression, anxiety and suicidal ideation, and the drug never made it to the U.S. market. By 2008, the EMA had recommended the suspension of the drug, and it was eventually removed from all markets entirely. 

Past studies, however, suggest that if used in combination, the insulin secretion effect of GLP-1 agonists could synergize with the insulin-sensitizing action of CB1 blockers for increased effectiveness. In diet-induced obese mice (here's an image because I know you want to see one), the co-administration of the two drugs achieved greater reduction in body weight and fat mass than monotherapies.

Novo hasn’t unveiled its plans for the assets yet, other than to say it will investigate the potential of Inversago’s lead asset, INV-202, for obesity and obesity-related complications. But obesity is a growing epidemic that has long lacked safe and effective treatments, so I’m eager to see what Novo does next.

—Karen Langhauser