Alfasigma is set to commence marketing Jyseleca in Europe after finalizing the transfer of marketing authorization within the European Union. This move follows the Italian pharmaceutical company's acquisition of the drug from Galapagos for €170 million, marking a significant expansion of Alfasigma's specialty pharmaceutical offerings.
Regulatory Approval and Market Transition
The European Commission (EC) has confirmed the marketing transfer of Jyseleca to Alfasigma, subsequent to the European Medicines Agency's (EMA) approval on August 2nd. This regulatory green light empowers Alfasigma to assume full responsibility for the marketing and distribution of Jyseleca across Europe.
Jyseleca: A Targeted Therapy for Inflammatory Conditions
Jyseleca (filgotinib) is an oral, once-daily, Janus kinase (JAK1)-preferred inhibitor. It is approved for the treatment of adults with moderately to severely active rheumatoid arthritis (RA) who have shown inadequate response or intolerance to one or more disease-modifying antirheumatic drugs (DMARDs). Additionally, Jyseleca is indicated for adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response, lost response, or were intolerant to conventional therapy or a biologic agent.
Alfasigma's Strategic Expansion
With this acquisition, Alfasigma strengthens its focus on specialty pharmaceutical products, incorporating Jyseleca into its portfolio within the therapeutic areas of gastroenterology and rheumatology. Alfasigma's Spanish subsidiary, located in Tortosa, Barcelona, spans 1,600 square meters and employs 1,475 individuals, managing a portfolio of fifty references. The company's Spanish branch was formed through the merger of Sigma-Tau and Alfa Wasserman in 2015, and previously, the merger of Geve Laboratories and Bama Laboratories in 2003.
Galapagos' Focus on Transformative Medicines
Galapagos, a global biotechnology company with operations in Europe and the United States, is dedicated to the development of transformative medicines aimed at improving the quality and duration of life. The company integrates science, technology, and collaborative approaches to cultivate a portfolio of therapies and biological products in oncology and immunology.
