So here's the thing about drug approvals: sometimes the FDA gives you a yes, sometimes a maybe-later, and sometimes both on the same Wednesday. That's what happened to Sanofi SA (SNY) this week.
The agency decided to take a little more time with Sanofi's subcutaneous version of its cancer drug Sarclisa, pushing the target action date back by up to three months to July 23. But in what feels like a consolation prize, the FDA separately said Sanofi can start giving its diabetes drug Tzield to much younger kids.
Let's start with the delay, because it's actually kind of interesting. The application is for Sarclisa (that's isatuximab-irfc, if you're keeping score at home) in a subcutaneous formulation. That means instead of getting it through an IV drip, patients could potentially get it via an on-body injector—a little device that delivers the medicine under the skin. If it gets the green light, this would be the first anticancer treatment delivered that way. Think of it as moving from a hospital infusion chair to something you might be able to use at home. For patients with multiple myeloma, that's not just a technical upgrade; it's a quality-of-life thing.
The FDA is reviewing this subcutaneous version for use in combination with standard regimens across all the same indications where the intravenous version is already approved. Nearly 60 countries have okayed Sarclisa for various uses, and more than 60,000 patients globally have received it. So this isn't a new drug; it's a new way to deliver an existing one.
While U.S. regulators are taking their time, Europe is moving ahead. Back in March, the European Medicines Agency's Committee for Medicinal Products for Human Use gave a positive opinion recommending approval of Sarclisa SC, including both the on-body injector and manual injection methods. A final decision from European authorities is expected in the coming months.
Now, about that other news. In a separate decision on Wednesday, the FDA approved expanding the use of Tzield (teplizumab-mzwv) to children as young as one year old. This therapy is designed to delay the onset of stage 3 type 1 diabetes in patients who already have stage 2 disease. Previously, it was only approved for patients aged eight and up.
The agency granted this approval under priority review, backing it with data from a phase 4 study called PETITE-T1D that looked at safety and how the drug moves through the body in younger children. Tzield is already notable as the first disease-modifying therapy indicated for delaying progression in early-stage type 1 diabetes. It's also under FDA review for an additional use in newly diagnosed stage 3 patients aged eight and older.
So, one delay, one expansion. The market seemed to take it in stride. Sanofi shares were up 0.87% at $47.54 during premarket trading on Wednesday.
