On Tuesday, GSK won approval for a drug the company predicts can reach up to $4 billion in peak annual sales.
The Food and Drug Administration cleared GSK’s depemokimab, which will have the brand name Exdensur, as an add-on maintenance treatment for those aged 12 years and older with severe eosinophilic asthma, becoming the first biologic approved with twice-yearly dosing.
The approval follows the recent backing of Exdensur by the Committee for Medicinal Products for Human Use, or CHMP, of the European Medicines Agency. The CHMP gave a positive recommendation to the drug across two indications: as an add-on maintenance treatment for severe asthma with type 2 inflammation, as well as for adults with chronic rhinosinusitis with nasal polyps that is inadequately controlled. The FDA has not approved Exdensur in the latter indication.
The FDA clearance is supported by data from two late-stage studies, titled SWIFT-1 and SWIFT-2, which found that Exdensur, when added to standard treatment and compared to a placebo, demonstrated a reduction in asthma attacks and hospitalizations. The drug is an ultra-long-acting biologic that targets “IL-5,” a protein thought to drive Type 2 inflammation.
GSK is entering a market already stacked with several competitors, including Sanofi and Regeneron’s Dupixent, AstraZeneca’s Fasenra, and the more recently approved Tezspire from AstraZeneca and Amgen. Yet GSK has maintained that its IL-5 inhibitor could become a blockbuster, as well as a new standard of care for those with severe asthma.
About 2 million Americans live with severe asthma, with half experiencing attacks that could lead to hospitalizations. Despite the availability of effective biologic drugs, less than 30% of eligible patients can receive these treatments. And according to GSK, 65% of new biologic patients discontinue therapy within the first year.
Approved medicines to treat severe asthma often come with long, multiple dosing schedules that could be difficult to adhere to and could lead to severe outcomes if not maintained.
“Physicians in the US now have the option to provide sustained protection from exacerbations for patients living with severe asthma with an eosinophilic phenotype in just two doses a year,” said Kaivan Khavandi, global head of respiratory, immunology & inflammation R&D, in a statement. “Exdensur could redefine patient care and further establish the use of biologics for those who continue to experience exacerbations despite treatment.”
In an email to BioPharma Dive, a GSK spokesperson said that the company will disclose the drug's price once it launches in January. The company is in "active dialogue" with the FDA regarding a future clearance in rhinusitis.
Editor's note: This story has been updated with comments from a GSK spokesperson.
