Galapagos Withdraws Jyseleca Applications in Europe and Revises Sales Projections
Galapagos, a Belgium biotech company, has experienced setbacks with its drug Jyseleca (filgotinib). Based on the results of a phase 3 study, the company has decided not to submit a Marketing Authorization Application (MAA) for Jyseleca in Crohn’s disease in Europe. Additionally, Galapagos will not proceed with its MAA for filgotinib in ulcerative colitis in Switzerland. These decisions have resulted in Galapagos slashing its 2023 sales projections for Jyseleca by around 40 million euros.
The company’s 2023 sales guidance for Jyseleca has been reduced from 140-160 million euros to 100-120 million euros. The JAK inhibitor is already approved in Europe for rheumatoid arthritis and UC. Galapagos attributed the changes to the evolving market and competitive landscape for the JAK class in Europe over the past six months.
This development represents a significant blow to Galapagos, which had been relying on the potential success of Jyseleca in these lucrative indications. However, the company still has a strong balance sheet with 3.9 billion euros on hand for business development.
Galapagos’ CEO, Paul Stoffels, who took over the position in March of the previous year, expressed a commitment to seeking differentiated global products in his efforts to drive innovation and bring life-saving therapies to patients. The company has seen its value decline significantly, facing challenges since the FDA rejected filgotinib in rheumatoid arthritis due to toxicity issues three years ago.
Despite the setbacks, Galapagos is focused on its immunology and oncology pipeline, concentrating on best-in-disease validated targets in strategic therapeutic areas with shorter time-to-patient potential. The company is now exploring strategic options for Jyseleca as it navigates these challenges and seeks opportunities for future growth and success.
