London : Sanofi has won an early green light from Britain for its game-changing eczema medicine, boosting the French company’s hopes for a product that is also expected to win approval in the U.S. market this month.
Britain’s medicines regulator has granted dupilumab a positive scientific opinion through its Early Access to Medicines Scheme, meaning patients can get the drug before it is granted formal marketing authorisation, Sanofi said on Tuesday.
Dupilumab has impressed doctors in a series of clinical trials over the past year and consensus analyst forecasts already point to annual global sales of more than $4 billion by 2022, according to Thomson Reuters data.
The medicine, which was developed with Sanofi’s long-time partner Regeneron Pharmaceuticals, is widely expected to win a U.S. green light by a March 29 action date set by the Food and Drug Administration.
Dupilumab works by inhibiting two proteins involved in the body’s immune response, known as IL-4 and IL-13, giving it an unusually wide range of potential uses. Beyond eczema, or atopic dermatitis, Sanofi believes it has the potential to help fight 14 different disorders, including asthma and food allergies.
Sanofi’s research head, Elias Zerhouni, told Reuters last week he had very high hopes for the medicine, which he said signalled “the emergence of the new science and portfolio at Sanofi”.
The Paris-based group needs to score some high-profile wins on the new drug front to offset flagging sales in its big diabetes business, where increasing competition and pressure on prices has hit sales and profits.