UK–based patients battling severe atopic dermatitis who failed to respond to all available approved therapies will now have access to the investigational drug Dupilumab.
Sanofi AG (SNY) and Regeneron Inc.’s (REGN) atopic dermatitis (AD) drug dupilumab secured clearance in the UK through the Early Access to Medicines Scheme (EAMS). Granted by the Medicines and Healthcare Products Regulatory Agency of the UK, EAMS allows eligible adult patients access to dupilumab before the drug is granted formal marketing authorization in the UK.
The formal marketing application of dupilumab is currently under review by the European Medicines Agency (EMA). In the United States, the drug’s Biologics License Application was accepted for priority review by the Food And Drug Administration (FDA) in September 2016 under the brand name Dupixent. It has a Prescription Drug User Fee Act target date of March 29, 2017. (For more, see Regeneron Eczema Drug to Be Reviewed in EU.)
The EAMS scheme was started in March 2015 in the UK to provide patients with severe or life-threatening conditions access to promising new drugs that are not yet licensed but are safe with benefits outweighing any possible side effects.
While atopic dermatitis (AD) is often viewed as just another "skin condition," it is a serious, chronic, inflammatory disorder capable of disrupting a patient's life. Also known as atopic eczema, AD leads to inflammation, intense itching and insomnia, as well as anxiety, depression and isolation among patients.
Dupilumab works by inhibiting the signaling of two key cytokines which are responsible for the immune response that is believed to be the fundamental reason for causing atopic dermatitis.
"Up until now, doctors have had little to offer even the most severe patients beyond an escalating routine of topical treatments and immunosuppressants. Dupilumab targets an underlying cause of the condition and gives us a new treatment approach for patients with the most clinical need," said Michael Cork, professor of dermatology and head of dermatology research at the University of Sheffield.
Sanofi and Regeneron developed the drug under a joint antibody collaboration established in 2007. The two pharmaceutical companies recently reported positive data from a drug combination involving dupilumab with topical steroids from a Phase 3 trial for patients with moderate-to-severe cases of atopic dermatitis. (See also, FDA Clears Regeneron, Sanofi Manufacturing Plant.)