Sanofi’s Dupixent (dupilumab) has received marketing authorization in India, after a long-running back-and-forth with regulatory authorities over clinical trial-related exemptions in the country.
Dupixent’s Long India Regulatory Journey
Dupixent’s regulatory journey in India appears to have spanned around four years, when Sanofi-Synthelabo first made an application in January 2019 to import and market the drug in India with a Phase III trial waiver. Pandemic-related delays perhaps didn’t make things easier.
In September 2019, a subject expert committee (SEC), which advises the Indian regulator on trial related clearances, suggested that the company conduct a local Phase III trial to assess the safety and efficacy profile of dupilumab in Indian patients.
Months later in November 2019, the French multinational submitted a request for reconsideration of its proposal for a trial waiver, citing India’s New Drugs and Clinical Trial Rules, 2019, which provide for a possible waiver of local clinical trials.
Sanofi explained that, at the time, Dupixent had been approved in over 40 countries/areas including the US, EU, Australia, Japan and Canada, with no major unexpected adverse events reported in the postmarketing phase.
The company also stated that the then ongoing Phase III global study for the asthma indication had Indian trial participants. Analyses from three Phase III trials had confirmed "low ethnic sensitivity", it added.
Sanofi also further committed to undertake a Phase IV study in India with safety as a primary endpoint and highlighted the fact there exists unmet need and “limitation in existing systemic therapies” available for patients with moderate-to-severe atopic dermatitis.
The SEC (dermatology and allergy) then re-deliberated Sanofi’s proposal in January 2020 but stuck to its stand, requiring a Phase III study in Indian patients.
The company then went on to request India's Technical Committee to review its application seeking marketing authorization for Dupixent in India with a Phase III trial waiver, while committing to undertake a Phase IV study. It also provided updated global clinical trial data on the efficacy of the therapy in patients with persistent asthma.
Interestingly, at the time the company also provided a letter from the Skin Allergy Research Society to buttress its case. The society expressed "surprise and concern" that such an important and transformative therapeutic option that was available in all major countries of the world had still not been made available to Indian patients.
The Technical Committee, however, in its meeting in April 2021 backed the SEC decision requiring the firm to undertake a Phase III trial to assess the safety and efficacy profile of the therapy in Indian patients
The blockbuster IL-4/IL-13 inhibitor has now been approved in the country for the treatment of adults with moderate-to-severe atopic dermatitis with a trial waiver, though the product’s regulatory
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