Adalvo announces it is preparing a DCP submission of its Mirabegron/Solifenacin fixed-dose combination (FDC) tablet.
This follows the company’s announcement of positive results from its pivotal fed study evaluating the FDC, consistent with earlier clinical findings that showed improved outcomes over monotherapy.
The FDC tablet is the first of its kind. Designed to support improved patient adherence, it offers a convenient and differentiated therapy for adults with Overactive Bladder (OAB) Syndrome, characterised by urgency, increased urination frequency, and/or urgency incontinence.
Achieved through advanced formulation complexity, tailored pharmaceutical development, and multi-region regulatory planning, the product is intended for launch following patent expiry in key markets, including the EU.
Adalvo is the only company to have launched Mirabegron monotherapy in early-access EU countries, highlighting its commitment to addressing unmet needs in urology and its ability to navigate regulatory and IP frameworks in high-barrier markets.
According to IQVIA, combined global MAT sales for Mirabegron and Solifenacin were estimated at $3.7 billion in 2024, with a 3% CAGR over the past three years, reflecting solid commercial potential in a mature yet growing market.
Adalvo will continue to expand its urology portfolio with differentiated assets. For licensing or partnership opportunities, please contact the Adalvo team.