(Bloomberg) -- Argenx SE’s Vyvgart Hytrulo shot gained US approval to treat a rare nervous system disorder, a win for the biotechnology firm after a series of setbacks. 

Vyvgart Hytrulo gained approval to treat chronic inflammatory demyelinating polyneuropathy, a condition that leads to muscle weakness and loss of sensation in the arms and legs. The drug has US clearance for generalized myasthenia gravis, another rare disease that affects the neuromuscular system. It’s also approved in an infused form called simply Vyvgart.

“Patients have been waiting, and today Argenx is delivering the first innovative treatment for CIDP in more than 30 years,” Luc Truyen, chief medical officer of the Brussels-listed company, said Friday in a statement.

The company faced a reversal earlier this month when it decided against moving forward with Vyvgart in postural orthostatic tachycardia syndrome. Tests showed it failed to benefit patients with the condition, which occurs when blood fails to reach the upper body when people stand up. Late last year, Vyvgart Hytrulo failed in trials of a rare bleeding disorder and pemphigus, a skin ailment.

Argenx’s trial last July showed that the shot lowered the risk of relapse 61% in people with the chronic nerve condition, compared with those who received a placebo.

Peak sales of the treatment in the new use could reach $3.05 billion, taking into account an addressable patient population of 36,000, KBC Securities analyst Thomas Vranken said in a note to clients on Thursday. That would also include a “slight pricing premium” over its use for myesthenia gravis, Vranken said. 

Argenx shares closed 3.7% higher in Brussels on Friday. 

--With assistance from James Cone.

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