The innovative drug GLPG1792 has been awarded fast track status by the FDA

Galapagos is a clinical biotech company focused on the discovery and development of small molecule drugs with new mechanisms of action, with pipeline assets covering preclinical to Phase III clinical assets for inflammation, fibrosis, osteoarthritis and other adaptations. Recently, the company announced that the U.S. Food and Drug Administration (FDA) has granted GLPG 1972/S201086 fast-track status for the treatment of osteoarthritis (OA). OA is a high incidence and disability disease. So far, there is no treatment to stop the progression of the disease, patients can only receive treatment for the disease, there are important unsealed medical needs in this area.
FDA's Fast Track program aims to accelerate drug development and rapid review for serious diseases to address critically unsolved medical needs in key areas. The fast-track status of experimental drugs means that drug companies can interact more frequently with the FDA during the development phase, and may be given priority FDA review after submitting a new drug application (NDA).
GLPG1972/S201086 was discovered by Galapagos and is being developed in collaboration with Schweija, with the potential to become a pioneering disease-modified osteoarthritis drug (DMOAD). Galapagos owns the exclusive commercial rights of GLPG1972/S201086 in the U.S. market, and Sveya owns the rights outside the U.S. market. Under the terms of the 2010 agreement, Galapagos will also be eligible for development, regulatory and commercial milestone payments, as well as tiered royalties for commercial sales outside the United States. In June this year, the two sides announced the launch of GLPG1972/S201086 for the treatment of patients with knee osteoarthritis in the 52-week Phase II clinical study ROCCELLA.
GLPG1972/S201086 is a DMOAD candidate drug that has been shown to target cartilage degradation enzymes called ADAMTS-5 in 2 animal models. In the Phase I study, the drug met safety and pharmacodynamics goals and reduced the academic level of the new AMGS table (a biomarker of cartilage damage) by about 50 percent within 2 weeks of treatment. In a recent Phase IB study, similar results were found within four weeks of the drug's treatment, reducing ARRS blood levels by 50 percent by dose dependence and providing good tolerance.
it's worth noting that Galapagos is also currently working with Gilead to develop filgotinib, a highly selective JAK1 inhibitor discovered by Galapagos, which reached a $2 billion deal with Galagos at the end of December 2015 to jointly develop filgotinib. This partnership will help strengthen Gilead's position in the field of inflammatory diseases, which will also be a new growth point for Gilead in the future, following the hepatitis C and HIV sectors.
currently, Gilead and Galapagos are conducting a number of studies to assess the potential of filgotinib to treat a variety of inflammatory diseases, including Phase III studies including the treatment of rheumatoid arthritis, Crohn's disease, and ulcerative colitis. In September this year, the filgotinib treatment RA was successful in phase III clinically. Given the good efficacy and excellent safety data of filgotinib, the industry believes that the drug will have an opportunity to lead the JAK inhibitor field when it is on the market. (Bio Valley)