Johnson & Johnson scores Darzalex convenience boost with OK for speedy new formulation

Johnson & Johnson is ready to take treatment time for multiple myeloma patients down from hours to just minutes with its new formulation of blockbuster Darzalex, and the approval for the New Jersey drugmaker couldn’t come at a more opportune time.

Friday, the FDA green-lighted Darzalex FasPro, a subcutaneous version of the top seller that can be administered over about three to five minutes, helping patients avoid lengthy infusions. The agency based the go-ahead on phase 3 head-to-head study data showing the newcomer could not only match the IV treatment in terms of efficacy, but cut down on infusion-related side effects, too.

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The company expects FasPro to offer “many advantages” to the marketplace—not the least of which is that it’ll dramatically shorten the amount of time patients need to spend in treatment centers at a time when many people are working to cut down person-to-person interactions thanks to the COVID-19 pandemic.

“Reducing the amount of time a patient would be exposed is certainly a major advantage,” Anthony Fernandez, VP of hematology sales and marketing for J&J’s Janssen unit, said ahead of the approval. “It’s fair to say that the COVID-19 pandemic and the general dynamic in the multiple myeloma community makes it even more urgent and gives us even more excitement” to launch the new product, he added.

The pharma giant also expects FasPro to have a “positive impact on the utilization of healthcare resources,” Fernandez said, ranging from easing the burden placed on physician staff to freeing up flexibility for scheduling patients.

J&J is hoping those factors convince doctors to switch patients to the new formulation, which Fernandez called a “really important advance in alignment with our commercial strategy.”

“We know infusion time is an important consideration for the selection of any multiple myeloma treatment,” he said, noting that the company hopes to see Darzalex adopted earlier in treatment—specifically, in the front-line setting and in early in relapsed disease.

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First, though, J&J will have to get the word out—not an easy task considering in-person detailing is certainly out of the question. But the drugmaker’s team is “exploring all avenues of communication” and leveraging a suite of virtual tools to get its messages across, and it’ll do it “with the same urgency as if we had the luxury of in-person visits and detailing.”

“There’s been a huge effort that has been underway now for weeks, and I personally feel incredibly confident in our ability to reach … the marketplace stakeholders that we need to educate given all the virtual technologies we have at our disposal and creative thinking on our commercial team’s front,” Fernandez said.