Case Study: Regeneron, Sanofi’s Dupilumab Development to approval

The U.S. Food and Drug Administration on Tuesday approved Regeneron Pharmaceuticals Inc and Sanofi SA’s drug for moderate-to-severe atopic dermatitis.

Bio-molecule: Dupilumab

Dupilumab is a monoclonal antibody designed for the treatment of atopic diseases. This drug is being developed by Regeneron Pharmaceuticals and Sanofi. The US Food and Drug Administration has designated dupilumab a “breakthrough therapy” which is designed to speed promising new drugs to market

Mechanism

It binds to the alpha subunit of the interleukin-4 receptor (IL-4Rα). Through blockade of IL-4Rα, dupilumab modulates signaling of both the interleukin 4 and interleukin 13 pathway.

Clinical Trials to Approvals:

In 2013 mid-stage data was presented at the American Thoracic Society meeting and published in the NEJM demonstrating an 87% (placebo: 67%) reduction in asthma exacerbations in patients with moderate-to-severe allergic asthma. In an atopic dermatitis study, 85%(36 percent or 85 out of 671 patients) of patients improved their symptoms by at least 50% within twelve weeks (measured by eczema area and severity index), versus 35% in the placebo group.

In 2016 good results were announced from the SOLO1 and SOLO2 phase III trials (for atopic dermatitis/eczema symptoms) and the US FDA granted it priority review status. On March 28, 2017, the U.S. Food and Drug Administration approved Dupixent (dupilumab) injection to treat adults with moderate-to-severe eczema.

In a pivotal late stage study, after 16 weeks of treatment with 300 milligrams of Dupixent either weekly or every two weeks along with topical corticosteroids, 39 percent had achieved clear or nearly clear skin compared with 12 percent of patients who received the topical treatment alone.

Pricing: 

Sanofi and Regeneron said the drug, Dupixent, will have a list price of $37,000 a year. But while the price before discounts and rebates to insurers is far more expensive than topical medicines and steroids currently used to treat eczema, it is less pricey than other injectable antibody drugs for serious conditions, such as psoriasis, that list for about $50,000 a year.

Drug Development Strategy:

Dupilumab had earned the FDA’s breakthrough therapy designation given to expedite development and review of medicines for serious or life-threatening diseases lacking effective treatments.

Indication Extension Plan:

Dupixent is also being developed for severe asthma, where it will compete with a wave of other new biotech medicines, such as GlaxoSmithKline’s Nucala, as well as for nasal polyps.