The US Food and Drug Administration has given the green light to the chief drug put out by Insmed (NASDAQ:INSM) to treat a rare type of lung disease called MAC disease, which previously faced limited treatment options.
Arikayce can now be used for the treatment of Mycobacterium Avium Complex (MAC) lung disease as part of a combination antibacterial drug regime for adult patients who face a shortage of treatment options.
Arikayce is the first and only therapy approved in the US for patients with MAC lung disease, a chronic and debilitating condition.
But Insmed shares failed to gain traction on the back of the announcement, slipping by 20.6% to $16.05 in Monday’s afternoon trading session on profit-taking.
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“The approval of Arikayce is a significant moment for adult patients suffering from MAC lung disease who have limited or no available treatment options,” said Will Lewis, CEO of Insmed in a statement. “It also represents an incredible milestone for our company which has taken this medicine from concept to approval and now will launch the drug across the US.”
Arikayce’s accelerated approval had been considered likely since the FDA’s advisory committee threw its weight behind the drug last month in a meeting.
As a condition of accelerated approval, Insmed is collaborating with the FDA on the design of an additional clinical study to support full approval.
The approval of Arikayce was based on results from Insmed’s ongoing Phase 3 Convert study, which showed that Arikayce improved sputum culture conversion rates.
Arikayce is an inhaled, once-daily formulation of amikacin, an antibiotic that was historically administered intravenously.
Patients with MAC lung disease suffer from a range of symptoms that often worsen with time, including chronic cough, fatigue, fever, weight loss and chest pain.
Arikayce’s label warns of further risk of respiratory problems such as airway constriction and inflamed lungs.