The U.S. Food and Drug Administration on Tuesday approved Regeneron Pharmaceuticals Inc and Sanofi SA's drug for moderate-to-severe atopic dermatitis, a product widely seen as the most important future growth driver for the two companies.
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.
"We are encouraged by the ongoing conversations we've had with health plans and pharmacy benefit managers about coverage for Dupixent for patients," Sanofi said in a statement.
Atopic dermatitis is a chronic type of skin inflammation also known as eczema, which in severe cases causes constant, often unbearable, itching.
Wall Street analysts forecast annual sales exceeding $4 billion by 2022 for the biotech drug known chemically as dupilumab, according to Thomson Reuters data.
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.
"This drug is really a game changer," said Dr. Emma Guttman-Yassky, Vice Chair of the department of dermatology at Mount Sinai Hospital in New York who conducted clinical trials of dupilumab.
"This condition is terrible for patients. They don't sleep at night. It's like having poison ivy all the time all over the body," she said, adding that patients lose work and can become so desperate they contemplate suicide.
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.
The drug works by blocking the IL-4 and IL-13 proteins involved in the body's immune response that Regeneron and Sanofi believe to be underlying causes of a number of complex conditions.
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.
Eczema affects an estimated 2 percent of U.S. adults, and as many as 10 percent to 20 percent of children. About a third of adults have moderate to severe disease.
Regeneron and Sanofi shares were up less than 1 percent each after the widely expected approval announcement.
(Additional reporting By Deena Beasley in Los Angeles and Ben Hirschler in London; Editing by Chizu Nomiyama, Bernard Orr)