French rare-disease specialist Advicenne has reached another milestone in its Middle East expansion. The company announced that Sibnayal®, its treatment for distal Renal Tubular Acidosis (dRTA), has received both marketing authorization and reimbursement approval in the United Arab Emirates.

The decision positions the UAE as the second Gulf Cooperation Council (GCC) country to approve Sibnayal, following Saudi Arabia’s authorization in July last year. For Advicenne, it’s not just regulatory progress—it’s a commercial and strategic validation in a region where dRTA prevalence is significantly higher than in Europe or the United States.

Why the UAE Approval Matters

dRTA is a rare but serious kidney disorder that disrupts the body’s acid-base balance, often leading to growth impairment, kidney stones, and long-term renal damage if left untreated. While the condition is considered ultra-rare in Western markets, genetic forms of dRTA are more common in the GCC, with an estimated 1,000 to 1,200 patients across the region.

That higher prevalence makes regulatory and reimbursement access especially critical. In the UAE, Sibnayal will now be both approved and reimbursed, removing a major barrier to adoption in a market where rare disease therapies often face delays or limited coverage.

The reimbursed annual treatment cost in the UAE is comparable to Saudi Arabia and aligned with top European pricing, signaling strong recognition of the drug’s clinical value by regional health authorities.

A Second GCC Win—and a Strategic Signal

This authorization reinforces Advicenne’s broader GCC strategy. Rather than pursuing isolated approvals, the company is methodically building regional momentum, leveraging success in one market to support approvals in neighboring ones.

Sibnayal is already being prescribed under early access programs in several GCC countries, including the UAE, which likely helped smooth the regulatory path. With full authorization now in place, Advicenne can transition from limited access to broader, more sustainable commercial rollout.

Importantly, Advicenne retains the marketing authorization, while its regional partner Taiba Rare handles local commercialization—a structure designed to combine centralized control with local market expertise.

The Role of Local Partnership

Advicenne credits much of its GCC progress to its collaboration with Taiba Rare, one of the region’s leading distributors of specialized and rare-disease medicines.

Didier Laurens, CEO of Advicenne, emphasized that the UAE approval reflects sustained joint effort rather than a one-off regulatory success.

“This additional marketing authorization in one of the GCC countries results from the tireless efforts of the teams at Advicenne and Taiba Rare,” Laurens said. “The reimbursed price recognizes the added value of the treatment and enables patients to be treated in a region where the prevalence is among the highest in the world.”

From Taiba Rare’s perspective, the approval strengthens its positioning as a key player in rare disease access across the Middle East.

“This milestone reflects our strong commitment to addressing rare diseases in the region,” said Saif Alhasani, CEO of Taiba Rare. “This approval represents important and positive news for the dRTA community in the UAE.”

Sibnayal and the Competitive Landscape

Sibnayal is a fixed-dose combination of potassium citrate and potassium bicarbonate, designed specifically to address the long-term management challenges of dRTA. By simplifying dosing and improving tolerability, it aims to improve adherence compared to traditional alkali therapies—an important factor in chronic pediatric and adult rare diseases.

In rare-disease markets, clinical differentiation matters, but pricing, reimbursement, and distribution often determine real-world impact. Securing reimbursement at a level comparable to leading European markets puts Sibnayal in a strong competitive position, particularly in a region where imported therapies can face steep pricing pressure.

A Broader Trend in GCC Healthcare

The UAE approval also reflects a broader trend across the GCC: greater prioritization of rare diseases and genetic disorders. As national health systems invest more heavily in specialized care and screening programs, regulators are increasingly willing to reimburse innovative therapies that address unmet needs—especially when prevalence is higher locally.

For biotech and specialty pharma companies, the GCC is evolving from a peripheral market into a strategically important region, particularly for rare and orphan indications.

What Comes Next for Advicenne

With Saudi Arabia and the UAE now secured, Advicenne has established a meaningful foothold in the Gulf. Additional GCC approvals could follow, supported by real-world use data and growing clinician familiarity with Sibnayal.

For patients, the immediate impact is clearer access to a reimbursed, purpose-built treatment. For Advicenne, the UAE decision strengthens both its revenue outlook and its credibility as a rare-disease player capable of executing beyond Europe.

As rare-disease innovation increasingly looks beyond traditional Western markets, Advicenne’s GCC progress offers a case study in how targeted partnerships and regional focus can unlock meaningful growth.

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