Advicenne's Sibnayal® Secures French Reimbursement for Kidney Disease

PARIS, France – February 02, 2026 – Patients in France suffering from distal Renal Tubular Acidosis (dRTA), a rare and debilitating kidney disease, can now access a breakthrough treatment with greater ease following the official reimbursement of Sibnayal® by the French social security system. The decision marks a pivotal moment for Advicenne, the Paris-based pharmaceutical company that developed the drug, concluding years of discussions and transitioning the treatment from a restrictive early access program to widespread availability in retail pharmacies.

This move is a significant victory for the estimated one in 100,000 people in France affected by dRTA, a condition where the kidneys fail to properly excrete acid into the urine. This leads to a buildup of acid in the blood, known as metabolic acidosis, which can cause severe long-term complications, including growth retardation in children, rickets, kidney stones, nephrocalcinosis, and progressive kidney failure.

A New Standard of Care for a Rare Disease

For years, the standard treatment for dRTA has been a burdensome regimen of alkaline therapies, often requiring patients to take pharmacy-compounded preparations up to six times a day, including overnight doses, to manage their condition. This demanding schedule posed significant challenges to adherence and quality of life, particularly for children and their caregivers.

Sibnayal®, a fixed-dose combination of potassium citrate and potassium bicarbonate, fundamentally changes this paradigm. Its formulation as prolonged-release granules allows for a simplified twice-daily administration, a major improvement that is expected to enhance treatment adherence and long-term outcomes. The French High Authority of Health (HAS) acknowledged this benefit in its December 2021 opinion, noting an expected improvement in care conditions due to the drug's delivery form and simplified dosing. It is now positioned as a first-line treatment for dRTA in adults, adolescents, and children over one year of age.

The new reimbursement decision means patients can now obtain their prescription directly from their local pharmacy, a stark contrast to the logistical complexities of the previous early access program. This simplified access is a profound relief for families who have navigated the difficulties of managing a chronic rare disease.

The Long Road to Reimbursement

The path to making Sibnayal® widely available to French patients has been a multi-year journey. After receiving Marketing Approval from the European Medicines Agency (EMA) in April 2021, Advicenne engaged in extensive discussions with French health authorities to secure reimbursement.

The publication of the decision in the French Republic's Official Journal on February 2, 2026, codifies the agreement. The published prices are set at €213.41 for the 24 mEq strength and €71.46 for the 8 mEq strength, with the national health insurance fund covering 70% of the cost. This decision not only provides a clear pathway for patient access but also establishes a stable commercial foundation for the product in its home market.

Didier Laurens, Chief Executive Officer of Advicenne, celebrated the milestone. "We have finally reached an agreement on the reimbursement of Sibnayal® after several years of discussions," he stated in a press release. "It is important that this product, developed in France, manufactured in France, and supported overwhelmingly by French investors, will now be made available to French patients in a simplified manner. We are thinking in particular of patients suffering from dRTA and treated with Sibnayal®, who will be able to access their treatment more easily through the French pharmacy network."

A Strategic Milestone for a French Innovator

For Advicenne, a specialty pharmaceutical company founded in 2007, this reimbursement is a critical strategic and financial victory. As the company's lead product, Sibnayal®'s success in its domestic market is essential to its growth and its goal of achieving operating profitability. With Sibnayal® now the only reimbursed medicine specifically for dRTA in France, Advicenne has secured a significant competitive advantage.

The company's financial reports from 2025 already showed strong momentum, with end-market sales of Sibnayal® across Europe and the Middle East more than doubling to €5.5 million in the first half of the year. The addition of the French market is expected to significantly accelerate this growth trajectory, providing a stable revenue stream and validating the company's focus on developing innovative treatments for rare nephrological diseases.

This achievement reinforces investor confidence and strengthens Advicenne's position as it continues to expand its commercial footprint. The company has already established partnerships to market Sibnayal® across numerous European territories, including Germany, Spain, and the Nordic countries, and recently secured market authorization in the United Arab Emirates.

Beyond dRTA, Advicenne is also pursuing late-stage development of the same drug candidate for cystinuria, another rare kidney disease, in Europe, the United States, and Canada. The successful reimbursement in France for dRTA serves as a powerful testament to the company's ability to navigate complex regulatory and pricing landscapes, bolstering its prospects for future approvals and market entries.