Sanofi's Dupixent scores double COPD win in US, China

After a long road that included a three-month delay as the agency pushed for additional data, the US FDA has approved Sanofi and Regeneron's Dupixent (dupilumab) for COPD - as has China's National Medical Products Administration (NMPA), which announced its approval the same day. It's the first ever biologic medicine for COPD in either country.

Specifically, the drug is indicated in both countries as an add-on treatment for patients with inadequately controlled COPD and an eosinophilic phenotype - about 300,000 patients in the US.

Dupixent is already approved in the US for a variety of indications, going back to eczema in 2017 (and most recently for the treatment of the rare skin condition prurigo nodularis), but its approval for COPD hit a setback in May when the FDA delayed the timeline for its verdict on the COPD indication from 27th June to 27th September, after asking Regeneron for additional efficacy data. In the meantime, the EU approved the drug in July.

These latest approvals come off the back of two successful trials: the BOREAS trial, which showed a 30% reduction in COPD exacerbations, and the NOTUS trial, which showed a reduction of 34%. In total, nearly 1,000 patients received the treatment across the two trials.

The drug is already a blockbuster thanks to the existing indications: sales hit $12 billion last year and analysts have suggested that COPD could help it to reach $20 billion by the end of the decade, when it will approach the end of its patent life.

“This latest FDA approval for Dupixent represents new hope for the hundreds of thousands of COPD patients in the US who can sometimes struggle just to breathe during their everyday lives," Dr George D. Yancopoulos, president and chief scientific officer at Regeneron, said in statement. "This latest approval represents an important next chapter for Dupixent, giving those with COPD a novel option that has demonstrated the unprecedented ability to help patients experience fewer exacerbations, while also helping them breathe better and improve quality of life in phase 3 studies.”

China has a high prevalence of COPD, but public awareness of the condition is limited, according to Sanofi. It's been the focus of a public awareness campaign by the Chinese government.

“China has the largest number of people living with COPD worldwide, and a significant proportion of patients are uncontrolled on current therapies and desperate for an effective treatment option," Dr Houman Ashrafian, EVP and head of research and development at Sanofi, said in a statement. "The Dupixent COPD clinical programme has furthered our scientific understanding of COPD, and given us a new way to think about which patients could benefit most from such a treatment. With its well-established safety and efficacy profile, Dupixent is a long-awaited advancement for patients, caregivers, and physicians who are desperate for a new treatment option.”

Other regulatory submissions are still pending, the company said, including in Japan.