Sanofi’s Chronic Lung Disease Drug Gets EU Regulator Backing
If approved, Sanofi's Dupixent will be the first-ever targeted therapy for the disease in the EU.
(Bloomberg) -- Sanofi’s Dupixent is close to being approved in Europe for use in helping patients with a chronic lung disorder, opening up another avenue of growth for the blockbuster drug.
The European Medicines Agency’s Committee for Medicinal Products for Human Use said the shot could be used as an add-on treatment for chronic obstructive pulmonary disease patients with high levels of some white blood cells, according to a company statement Friday. The European Commission is expected to decide on the application in the coming months, it added.
If approved, Dupixent will be the first-ever targeted therapy for COPD in the EU. It will also be the first new treatment approach for this life-threatening inflammatory lung disease, which causes obstructed airflow from the lungs, in more than a decade, the company said.
The US Food and Drug Administration is also reviewing the drug for COPD and could decide by Sept. 27, Sanofi said. Regulators in China are also considering the matter.
Shares of Sanofi were little changed in early trading.
Read More: Sanofi’s Dupixent Shows Strong Efficacy in Second Lung Trial
Dupixent, developed with Regeneron Pharmaceuticals Inc., is already one of the industry’s top-performing medicines. It’s currently prescribed for ailments ranging from asthma to some skin conditions. Sanofi recorded €10.7 billion ($11.6 billion) in sales from Dupixent last year, with demand still growing fast around the world.
The recommendation is a step forward for Sanofi Chief Executive Officer Paul Hudson, who is looking to transform the French drugmaker into a global powerhouse at developing next-generation therapies. Hudson surprised investors in October with a plan to increase drug-development spending, a decision that meant abandoning some older profit targets for now in hopes of creating more growth later this decade. The company is pushing a dozen potential top-selling medicines through costly clinical trials.
Read More: Sanofi CEO Shocks Investors With R&D Spending, Few Details
Two successful late-stage studies of Dupixent in people with COPD surprised many industry analysts, who had previously seen new therapies fail to help the condition, including AstraZeneca Plc’s Fasenra and GSK Plc’s Nucala.
(Updates to add shares in fifth paragraph)
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