Second Biologic to Make Entry for Moderate-to-Severe Asthma

The FDA’s approval of dupilumab, already approved for severe eczema, for asthma makes it the second biologic for the incurable lung disease. Dupilumab, branded as Dupixent by Regeneron and Sanofi, was cleared as an add-on maintenance treatment for moderate to severe asthma in patients 12 years of age and older.

Dupilumab is more expensive than omalizumab, but it works on additional pathways than omalizumab and can also be administered at home, while omalizumab must be given in a doctor’s office.

In its press release, the companies said the wholesale acquisition cost (WAC) will remain unchanged for the new indication.

Dupilumab has a WAC of $37,000 a year, up from $30,000 when it first launched for eczema. The companies raised the price effective June 29.

On GoodRx, a prescription pricing website for consumers, the average retail price for dupixent was $3274.11 for two 150 mg/ml syringes. For omalizumab, the price was $1317.40 for one 150 mg vial.

Dupilumab is the first drug to target the interleukin-4 (IL-4) IL-4 and IL-13 pathways in type 2, or eosinophilic asthma. Last year, the FDA approved dupilumab for the treatment of adults with moderate-to-severe atopic dermatitis whose condition is not properly controlled with topical therapies.

Eosinophilic asthma is a severe form of the condition that doesn’t respond well to inhaled corticosteroids, even at high doses. White blood cells called eosinophils become overactive, causing inflammation that blocks the airway with fluid and mucous. This can cause bronchial spasms. Unlike forms of asthma that are triggered by allergies or an environmental reaction, patients with this condition do not typically have a history of allergies.

Asthma affects approximately 40 million individuals, including 10 million children in the United States.

In a research note from Raymond James, analyst Laura Chico, PhD, said that “uptake in the atopic dermatitis market remains solid,” and that the drug’s asthma label—which includes patients who either have the eosinophilic type of asthma or who are dependent on oral corticosteroids—is unique. By 2026, 30% of the drug’s estimated $8.4 billion in revenue is expected to come from its asthma indication.

In an email to The American Journal of Managed Care^® (AJMC^®), executives from both companies (Michael Jones, vice president, Immunology Commercial Business Unit, Regeneron, and Namish Patel, vice president, Global Program Head Dupilumab, Sanofi) discussed their expectations for dupilumab.

AJMC^®: What are your expectations for payer pickup for this?

Jones: Discussions with payers/insurers have been positive to date and will continue on an ongoing basis, and we are working towards coverage beginning with payers within 30 days. We have a shared goal with patients, physicians, and payers/insurers to reduce the burden of moderate-to-severe asthma and will continue working with payers/insurers to ensure appropriate patients gain access to Dupixent as quickly as possible.

AJMC^®: What is the cost as compared to omalizumab?

Jones: We cannot comment on the price of Dupixent compared to other asthma biologics. That being said, we are committed to bringing innovative treatment options to patients where an unmet need exists. We believe patients need access to innovative medicines, and we balance this with the value they bring to healthcare systems.

AJMC^®: Does it carry a black box warning or have a risk of anaphylaxis like omalizumab?

Jones: There is no black box warning but in asthma patients, Dupixent can cause serious side effects including allergic reactions (including a severe reaction known as anaphylaxis) and rarely, inflammation of blood vessels. In the asthma clinical trials, the adverse reactions that occurred with Dupixent at a rate of at least 1% and more frequently than the respective comparator were injection site reactions, pain in the throat, and cold sores in your mouth or on your lips.

AJMC^®: What other indications is dupilumab being studied for?

Patel: Sanofi and Regeneron are also studying dupilumab in a broad range of clinical development programs for diseases driven in part by type 2 inflammation, including chronic rhinosinusitis with nasal polyps (phase 3), pediatric asthma (phase 3), pediatric atopic dermatitis (phase 3), adolescent atopic dermatitis (phase 3), eosinophilic esophagitis (phase 3), grass allergy (phase 2) and peanut allergy (phase 2), and a future trial is planned for chronic obstructive pulmonary disease. Dupilumab is also being studied in combination with REGN-3500, which targets IL-33. These potential uses are investigational and the safety and efficacy have not been evaluated by any regulatory authority.