Sanofi and Regeneron Pharmaceuticals announced  that the FDA approved Dupixent (dupilumab) for the treatment of severe itching known as atopic dermatitis in patients whose symptoms are not controlled by topical steroids.
It is also the first biologic medicine cleared for the condition.

Regeneron cofounder, chairman and chief executive Leonard Schleifer, thinks is a fair list price: $37,000 per patient per year, a price that he admits is still expensive, but is cost-effective.

Regarding pricing, Sanofi Genzyme chief executive David Meeker acknowledged “it won’t be the cheapest drug,” adding “we’ve had very constructive conversations with payers as we try to find that balance.”

Dupixent was approved based on three placebo-controlled clinical trials with a total of 2,119 adult participants. They were more likely to have clear or almost clear skin if they received Dupizent, an injection, not a placebo.

Schleifer points out that Dupixent costs less than drugs for psoriasis, which cost $50,000 per year. But the $37,000-a-year list price of the year is more than the $20,000-to-$30,000 price range expected by analysts at RBC Capital Markets, an investment bank, in their financial models.

One good news for patients whose drug benefits are managed by Express Scripts is that they will be able to get Dupixent without the need  of special documentation to prove they meet the criteria for taking the drug.

Express Scripts has chosen to not restrict the drug based on what percentage of a patient’s body is covered with broken, itchy skin, even though it could have. “As a clinician, I can tell the number of patients who have this just on their hands, and they have sores and bleeding cracks on their hands,”  said Steve Miller, the chief medical officer of Express Scripts,. “It’s not a huge body surface area. But it’s debilitating for those patients.”

On the ohter hand, CVS Caremark, the other big pharmacy benefit manager, says: “As we prepare for the approval of this medication, we are developing programs for our clients to ensure this new therapy is available for those patients with a demonstrated medical need for the drug, based on its indications as approved by the FDA.”

The market for the new eczema injectable drug could be 300,000 to 350,000 eligible patients, so investors will watch closely to see if insurers throw up reimbursement roadblocks to limit their cost exposure to the drug.

Wall Street analysts expect $200 million in 2017 sales  from Dupixent, an ammount which is higher than the first-quarter sales of Humira or Enbrel, rheumatoid arthritis medicines that are among the world’s best-selling drugs.

Also  analyst Jeffrey Holford of Jefferies LLC wrote that “market expectations for Dupixent are high given the unmet need in this patient group,” with sales expected to climb slowly to about $3.4 billion in 2025.

Regeneron and Sanofi shares were up less than 1 percent each after the widely expected approval announcement.

Sources: Forbes, The Wall Street Journal, Boston Business Journal