Adalvo announces the successful submission of its DCP application for Cladribine Tablets 10mg in the EU, following the expiry of data exclusivity.
Cladribine is indicated for the treatment of adult patients with highly active relapsing multiple sclerosis (MS), a chronic and disabling neurological disease with significant long-term management needs. According to IQVIA, global sales for Cladribine reached $1.4 billion in 2024, with a 3Y CAGR of 13%, highlighting its continued clinical and commercial relevance.
The program, which included a pivotal bioequivalence study, reflects Adalvo’s ability to deliver on high-barrier development projects with precision in both technical execution and regulatory strategy.
With a clearly defined approval pathway and launch planning aligned to regulatory milestones, Adalvo strengthens its neurology portfolio with another ready-to-launch product designed for competitive Day-1 market entry.
To explore licensing or commercial opportunities within Adalvo’s neurology portfolio, contact the team today.