Dupixent’s active ingredient is dupilumab, an antibody that binds to interleukin-4 (IL-4) receptor alpha subunit (IL-4Ra) – a protein that causes inflammation – inhibiting the inflammatory response that plays a role in the development of eczema (atopic dermatitis).
And yesterday the US Food and Drug Administration (FDA) approved its use to treat adults with moderate-to-severe eczema after evaluating it under the expedited Breakthrough Therapy designation pathway.
“To date, there have been few options available to treat people with moderate-to-severe atopic dermatitis who have uncontrolled disease,” said Julie Block, CEO of the National Eczema Association. “That’s why today’s approval of Dupixent is so important for our community. Now we have a treatment that is expected to help address patients suffering from this devastating disease.”
The drug has a Wholesale Acquisition Cost (WAC) of is $37,000 annually in the US, though Sanofi says discounts, rebates and assistance programmes are likely to reduce the cost to the patient.
The two firms are now hoping for regulatory approval of Dupixent for other indications and are undergoing Phase III trials for persistent uncontrolled asthma, and Phase II trials for nasal polyposis and eosinophilic esophagitis.
Regeneron and Sanofi
Since 2007, Regeneron and Sanofi have collaborated on a number of monoclonal antibodies including the 2015 approved cholesterol lowering Praluent (alirocumab) and Kevzara (sarilumab), approved last month by Health Canada for rheumatoid arthritis (RA).
US approval of Kevzara has been delayed due to an FDA complete response letter citing manufacturing deficiencies at Sanofi’s fill/finish facility in Le Trait, France. The site – located about 100km northwest of Paris – also does fill and finish for Dupixent.
Kevzara’s active ingredient is made at Regeneron’s Rensselaer, New York facility, as is the API for Dupixent, which was created using Regeneron's VelocImmune technology platform.
But Sanofi has also said extra manufacturing capacity for the biologic could be utilised at a CHF 290m ($288m) facility being constructed in partnership with Sanofi's strategic contract manufacturing partner Lonza when completed early next decade.