FDA gifts Alexion quick OK for Soliris follow-up Ultomiris

FDA
The FDA approved Ultomiris well ahead of a February decision deadline. (Andrew Harnik, Associated Press)

Alexion was expecting a decision on its Soliris successor by February, but thanks to a quick review from U.S. regulators, it’s made its way onto 2018’s list of new drug approvals.

The agency green-lighted the drug, Ultomiris, last week as a treatment for rare and life-threatening blood disease paroxysmal nocturnal hemoglobinuria. The new and improved version of Soliris requires follow-up dosing just every eight weeks, compared to its predecessor’s two-week regimen.

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Now, Alexion will be working to switch patients over to the new product, and a price break could help do the trick. The biotech has priced Ultomiris at a 10% discount to pricey Soliris, which has maintenance doses running about $508,000 in PNH, Leerink Partners’ Geoffrey Porges wrote in a note to clients. And if Ultomiris can rack up the additional indications Soliris bears, that discount could jump to 30%.

Ultimately, while “investors may react negatively to the initial impact of this pricing headwind,” Porges views the pricing decision as an important one for Alexion’s longer-term revenue outlook.

“Alexion’s decision to move toward more sustainable pricing with a superior product should … build toward a more stable revenue trajectory and longevity than currently expected,” he said, adding that “faster and greater switching” from Soliris to Ultomiris should help the franchise “prove more durable and protected from competition.”

RELATED: Alexion eyes $500M-plus in new Soliris sales with latest rare-disease win

Meanwhile, the company is ready to go with its new product despite the early OK from regulators. “Our conversations with the company indicated that they had prepared for an early approval possibility, and product is ready for the channel immediately,” Porges wrote.

Sales rep orientation won’t take place until January, but those detailing the drug are already selling Soliris, so they’ll be “well-prepared to highlight the Ultomiris label already,” he said.

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