GlaxoSmithKline may have some new Nucala competition in severe asthma, but it also has a new market all to itself.
Tuesday, the company nabbed an FDA approval for the treatment of eosinophilic granulomatosis with polyangiitis (EGPA), a chronic rare disease caused by inflammation in the walls of blood vessels.
Nucala is the first targeted therapy to win an approval in EGPA, and it’ll be a new option for the 5,000 or so EGPA patients living in the U.S. The current approach to managing the disease involves reducing active inflammation and suppressing the immune response by using corticosteroids and other agents whose long-term use can cause complications, GSK says.
"This approval follows the positive results of the largest prospective treatment study conducted in EGPA to date, and now for the first time physicians have a targeted treatment option for this debilitating condition," Eric Dube, SVP and head of GSK's global respiratory franchise, said in a statement.
The regulatory win comes not long after a big approval for GSK rival AstraZeneca, whose Fasenra moved in to challenge Nucala, as well as Teva’s Cinqair, in severe eosinophilic asthma. AZ’s contender requires less frequent dosing than its peers do, and it bears a lower price tag, too.
Sporting a two-year head start in the market, though, Glaxo is “ready to fiercely compete,” Cheryl MacDiarmid, GSK’s SVP of primary care, said in a recent interview—and it’s doing so, in part, by expanding to areas where its rivals aren’t.
In November, the British drugmaker filed for a nod in chronic obstructive pulmonary disease (COPD), and it’s trialing Nucala in other areas—including nasal polyps—as well.