(Bloomberg) -- Sanofi’s Dupixent has been cleared for a chronic lung disorder in the US, in another milestone for the blockbuster drug after a similar decision by European regulators.
The US Food and Drug Administration gave a green light to the shot as an add-on treatment for some patients with chronic obstructive pulmonary disease, Sanofi said in a statement Friday. Dupixent improved lung function and boosted quality of life for patients with COPD in two landmark studies, Sanofi said.
The medicine, developed with Regeneron Pharmaceuticals Inc., is already one of the industry’s top performers. It’s currently prescribed for ailments ranging from asthma to some skin conditions. It’s also now the first new treatment approach in more than a decade for COPD, a life-threatening inflammatory respiratory disease that causes obstructed airflow.
Dupixent is approved for patients with COPD that’s not adequately controlled and who have high levels of a type of white blood cell called eosinophils. European regulators backed the treatment in August.
The FDA clearance comes as Sanofi Chief Executive Officer Paul Hudson looks to turn the French drugmaker into a global powerhouse with a slew of next-generation therapies.
Hudson has increased spending on drug development, abandoning old profit targets in the short term, in hopes of achieving even greater growth later. The company is now pushing a dozen potential top-selling medicines through costly clinical trials.
Two successful late-stage studies of Dupixent in people with COPD surprised many industry analysts. Several therapies previously failed to help the condition, including AstraZeneca Plc’s Fasenra and GSK Plc’s Nucala, which lowered expectations for a breakthrough.
Dupixent’s revenue for Sanofi may grow to €21 billion ($23.5 billion) annually by 2030, according to analyst estimates compiled by Bloomberg. The drug will then begin seeing patent expirations, allowing for cheaper competing products in subsequent years.
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