Fast Track designation for Galapagos’ osteoarthritis treatment
Galapagos announced that the FDA has granted GLPG1972/S201086 Fast Track designation for the treatment of patients with osteoarthritis (OA).
The US Food and Drug Administration’s (FDA’s) Fast Track program is designed to facilitate the development and expedite the review of drugs that treat serious or life-threatening diseases or conditions and that demonstrate the potential to address unmet medical needs. Drugs that receive this designation are eligible for more frequent interactions with the FDA and are potentially eligible for priority review and rolling review of a New Drug Application (NDA). The purpose of this FDA program is to get important new drugs to patients earlier.
Galapagos is developing investigational molecule GLPG1972/S201086 with the potential to become a first-in-class disease-modifying osteoarthritis drug (DMOAD) as part of a collaboration with Servier signed in 2010. Galapagos has full US commercial rights to GLPG1972/S201086, with Servier retaining the ex-US rights. Under the terms of the agreement, Galapagos is also eligible to receive development, regulatory and other milestone payments plus royalties upon commercialization outside the US. In June 2018, Galapagos and Servier announced the start of the global 52-week ROCCELLA Phase 2 trial with GLPG1972/S201086 in knee osteoarthritis patients.
“The Fast Track designation by the FDA is a recognition of the high unmet medical need in OA, and the potential of GLPG1972/S201086 as a new treatment option,” said Dr. Walid Abi-Saab, CMO of Galapagos. “Together with our collaboration partner Servier, we look forward to accelerating the development of GLPG1972/S201086 as a potential first disease-modifying osteoarthritis drug.”