The Zhitong Finance App learned that Dupixent, a major drug from Sanofi-aventis (SNY.US), has been approved for use in patients with chronic lung disease in Europe, opening up a new growth path.
European regulators became the first country in the world to approve the vaccine as an add-on treatment for patients with chronic obstructive pulmonary disease (some high white blood cell levels), according to a statement from the company on Wednesday. In two landmark studies, the drug reduced worsening of the condition, improved lung function, and improved quality of life.
The company said the decision makes Dupixent the first targeted treatment for around 220,000 adult COPD patients in the European Union and the first new treatment for this life-threatening inflammatory respiratory disease in more than a decade.
Sanofi said the US Food and Drug Administration is also reviewing the drug's COPD treatment and may make a decision before September 27. Chinese and Japanese regulators are also considering it.
Dupixent, developed in collaboration with Regeneron Pharmaceuticals, is already one of the best performing drugs in the industry. Currently, the drug is used to treat a variety of conditions, from asthma to certain skin diseases. Sanofi received 10.7 billion euros ($11.5 billion) in sales from DuPont last year, and global demand for DuPont is still growing rapidly.
According to Bloomberg analysts, Sanofi's annual sales from DuPont may exceed 20 billion euros by 2030. At that time, the patent for this drug will expire, and there will likely be more affordable competition in the market in the next few years.
For Sanofi CEO Paul Hudson, this European approval is a huge victory, and he hopes to upgrade the French pharmaceutical company to a global giant through a series of next-generation treatments.
Investors were shocked by Hudson's plan to increase spending on drug development in October of last year. This plan requires him to abandon some profit targets in order to boost growth by the end of this century. The company is currently promoting more than a dozen potentially best-selling drugs through expensive clinical trials.
Dupixent's two successful late-stage studies on COPD patients surprised many industry analysts. Previously, several treatments such as Fasenra from AstraZenra (AZN.US) and Nucala from GlaxoSmithKline (GSK.US) failed to treat the disease, which lowered expectations for a breakthrough.