Sanofi India reported that the Deputy Commissioner of State GST, Ahmedabad, Gujarat, rejected its refund application of ₹11,62,853 for the period 2014-15 to 2017-18. The order, received on June 23, 2026, stated that the refund claim arises from a debit of the Electronic Credit Ledger (ECL) towards mandatory pre-deposit under the Central Excise Act, 1944, and not as tax under the CGST Act, 2017. Consequently, the authority ruled that the application is not maintainable before State GST as the matter falls under the domain of Central GST.

Details of the Order

The rejection follows the company's filing of an appeal under the Central Excise Act, 1944, for the period 2014-15 to 2017-18 (till June 2017). During this process, the company had paid a mandatory pre-deposit of ₹11,62,853 by debiting its ECL. It subsequently filed an application for the refund of this amount before the State GST authorities.

The table below outlines the key details of the regulatory order:

Company Response and Impact

In response to the order, Sanofi India stated that it intends to file appeals before the relevant Appellate Authorities. Regarding the consequences of this regulatory action, the company confirmed that there is no material impact on its financial, operational, or other activities.

Sanofi SA secured regulatory approval in Europe for Cenrifki (tolebrutinib) to treat adults with non-relapsing secondary progressive multiple sclerosis (SPMS), marking the first disability-targeting medicine for this specific patient population in the region. The approval addresses a critical unmet need, though the drug continues to face safety challenges following a rejection by U.S. regulators. The European Commission's decision is supported by results from the Phase 3 HERCULES study, which demonstrated that Cenrifki significantly delayed the onset of disability progression in patients with non-relapsing SPMS.

Clinical Trial Overview

The approval relies on data from three key phase 3 studies evaluating the efficacy and safety of tolebrutinib across different forms of multiple sclerosis.

Safety Profile and Regulatory Challenges

The safety profile of Cenrifki was consistent across the clinical program, with the most common adverse events being COVID-19 and upper respiratory tract infections. However, significant liver enzyme elevations were observed, and drug-induced liver injury (DILI) was identified as a potential safety risk. In December 2025, the U.S. Food and Drug Administration (FDA) issued a complete response letter for the new drug application, determining that the proposed risk evaluation and mitigation strategy could not adequately mitigate the serious risk of severe DILI. Consequently, Sanofi booked a 1.66 billion-euro write-down on tolebrutinib alongside its 2025 results.

Launch Plans and Risk Management

Sanofi plans to make Cenrifki commercially available in Germany later this year. The launch will be supported by a required Risk Management Program and a robust Patient Support Program, involving close collaboration between local medical teams, MS specialists, and patients. Strict adherence to liver monitoring requirements and prompt management of enzyme elevations are necessary to mitigate the risk of liver injury. Cenrifki is an oral, brain-penetrant Bruton's tyrosine kinase inhibitor designed to target smoldering neuroinflammation, a key driver of disability progression.

Additional Regulatory Milestone in Japan

Separately, Japan’s Ministry of Health, Labor and Welfare granted marketing and manufacturing authorization for Wayrilz (rilzabrutinib) for persistent or chronic immune thrombocytopenia (ITP) in patients who have not responded adequately to existing therapies. The approval was based on data from the Phase 3 LUNA 3 trial involving 202 adults, where 23% of patients receiving Wayrilz achieved a durable platelet response at week 25, compared with none in the placebo group.