FDA approves first postpartum depression pill from Biogen, Sage

The U.S. Food and Drug Administration has approved the first pill to help treat postpartum depression. The pill was co-developed by Biogen (BIIB) and Sage Therapeutics (SAGE). The approval was a mixed bag for the companies. It was not approved to treat for major depressive disorder, which would have been made the pill marketable to more patients. Also, there was a surprise warning from the FDA about not driving for 12 hours after taking the pill. The drugmakers say the pill should be ready for launch in the fourth quarter of 2023. Yahoo Finance Health Care Reporter Anjalee Khemlani explains the pill's approval.

Video Transcript

BRAD SMITH: In a milestone ruling for the pharmaceutical industry, the FDA has approved the first pill to help treat postpartum depression. Yahoo Finance's Anjalee Khemlani is here with the details and the latest update. Hey, Anjalee.

ANJALEE KHEMLANI: Hey, Brad. That's right. First of all, a record, of course, for the industry. First pill for postpartum depression, like you said. And that is for Sage and Biogen, two companies that work to codevelop and co-commercialize this pill. The FDA did give them the OK on Friday. And the company said they're ready for a Q4 launch.

But two major setbacks, the first that it was not approved-- this pill was not approved for major depressive disorder, and that would have given the companies much broader commercialization opportunity. Secondly, the surprise warning from the FDA about no driving 12 hours after taking the pill for Zurzuvae. It is a 14-day course.

And so the trials that they already conducted show that there was driving impairment. And that caught analysts a little bit by surprise, which is why the stock took a little bit of a dive earlier. We do know that there are also some questions about whether or not the partnership will continue as a result of the setbacks.

We did get comment from Biogen earlier today. In a statement to Yahoo Finance, they did say that they are continuing the partnership and, quote, "look forward to continued collaboration throughout the launch." So there were some concerns that because of these, Biogen might have been a little bit cooler towards continuing that partnership.

No word yet on whether or not they will continue any trials as necessary, as recommended by the FDA, to get approval for major depressive disorder, or MDD. And so that remains something we need to hear about from the two companies. But we do know that, of course, this is a game changer for women. And we do know that there will be some impact to the companies on the negative side.

So Sage has said in a call with investors this morning that because of this reduced commercialization opportunity, they will need to look at their pipeline and look at possible reorganization of the company. But they do have cash on hand until 2025, so they have a little bit of leeway there. And it looks like analysts have at least downgraded-- investors have downgraded this stock for Sage across the board as a result of these setbacks.

Leerink Partners said in a note today that they were previously thinking the indication could drive sales in the $250 to $400 million range, but they would probably put it at the lower part of that range because of that initial setback, and then looking at the warning label as well. So a lot of unexpected activity on that front for the companies. So, well, on the plus side, you know, definitely some positives for women.

This is going to affect state policies as well, which allow for Medicaid to cover and therefore give broader access. And while it is going to be a scheduled drug, there was conversation on the call this morning-- I thought this was interesting-- about potentially off-label use, even though it is a scheduled drug. So that does still open the door for potential for MDD use, but it's unclear right now. So a little bit of a mixed bag of results here, if you will.

JULIE HYMAN: Yeah, really interesting. Good news for women, even if it's not necessarily as good news as investors wanted for Sage. Just take a step back for a second, Anj. I'm just curious about the science here. If we can delve into that a little bit. Like, how is this different from antidepression drugs that are on the market? And why was there so much sort of excitement over this milestone drug, specifically for postpartum depression ?

ANJALEE KHEMLANI: Most of the others do just deal with depression generally. But because of the different aspects that go into postpartum depression, including the fact that breast milk is also affected by, you know, whatever you take, that was one of the things that was discussed on the call, is this part of it. So, you know, many different factors on exactly what these drugs target and how they might affect more broadly.

But just like you're seeing with this drug, it could be used off label. There are others out there that can be used dosing-wise as well, you know, whether or not say for the mother. All of these factors come into play when it comes to approval for this kind of drug.

BRAD SMITH: Yahoo Finance's own Anjalee Khemlani tracking the latest developments around this and the market action that we're seeing in reaction to this. Anjalee, thanks so much.