The first biologic to treat atopic dermatitis, Sanofi and Regeneron’s dupilumab, could launch in the US by Q2 2017, and the potentially game-changing drug could achieve annual sales of over $1.3 billion in this market by 2022, according to an analyst with research and consulting firm GlobalData.
Following impressive top-line Phase IIb safety and efficacy data in moderate-to-severe atopic dermatitis patients in July 2014, dupilumab has been assigned a Breakthrough Therapy designation by the US Food and Drug Administration.
Abhilok Garg, Ph.D., GlobalData’s Analyst covering Immunology, states that if dupilumab’s ongoing Phase III trials, which were initiated in September and October this year, are positive and the drug gains regulatory approval in the US, it will enter a market where there are currently no biologics and few effective options for moderate-to-severe atopic dermatitis patients.
Garg explains: “These patients must commonly resort to cyclosporine when a systemic agent is required, but cyclosporine is not a viable long-term maintenance treatment, due to the risk of nephrotoxicity associated with its prolonged use.
“If first to market, dupilumab would gain a competitive edge and the opportunity to set a precedent in terms of price. The drug’s path to approval is therefore being closely watched by other drug manufacturers, such as Bristol-Myers Squibb. This company is developing BMS-981164, an anti-interleukin-31 biologic about which leading dermatologists have expressed excitement.”
Following its launch, GlobalData envisions little competition for dupilumab, due to the lack of topical treatments’ popularity among most atopic dermatitis patients and the strong efficacy of the drug in its target patient segment. Furthermore, the treatment may also prove able to treat other, often connected conditions.
Garg comments: “Simultaneous late-stage trials assessing dupilumab’s potential as a treatment for nasal polyps and asthma are currently underway. These diseases commonly present in patients with atopic dermatitis in a phenomenon known as the atopic march.
“A drug that is able to target all of these related diseases would likely gain payer backing and a strong foothold across the major pharmaceutical markets, as its manufacturer could justify a premium price on the basis that this single product can control more than one of these highly prevalent chronic conditions.”