Osteoarthritis Drug Receives Fast Track Designation from FDA

FDA, MSAs, Rx/Pharmacy on February 21, 2019
Posted by Leah King, PharmD, JD and Marilyn J. Larrimer, RN, BSN, JD

In late November 2018, the FDA announced that it was granting Fast Track designation to an investigational drug for the treatment of osteoarthritis (OA). The drug, developed by Galapagos, is known by its identifier GLPG1972/S201086.  This drug is one to watch, since it has a novel mechanism of action for this therapeutic category. GLPG1972/S201086 is a disease-modifying agent that works by targeting ADAMTS-5, which is an enzyme that degrades cartilage. This is notably different than other drugs used in the treatment of OA, which produce their effect by inhibiting the inflammatory pathway (e.g. non-steroidal anti-inflammatory drugs), by supplementing cartilage in the knee joints (hyaluronic acid injections) or by simply masking the pain associated with OA (opioid or non-opioid analgesics).

Data from phase I trials is promising. The results from two trials of short duration (two weeks and four weeks) showed a decrease of approximately 50% in blood levels of ARGS neoepitope (a component of joint fluid). Treatment with GLPG1972/S201086 was well tolerated in both studies. The drug is moving forward to a larger, long-term study involving approximately 850 patients from 15 different countries. The study, which will be coined the ROCCELLA study, will evaluate the effectiveness of three different once-daily doses of GLPG1972/S201086. ROCCELLA will measure cartilage loss after 52 weeks of treatment with the three dosage levels.

Fast Track designation is granted by the FDA to facilitate the development and expedite the review of drugs designed to treat serious conditions and fill an unmet medical need. This is certainly a promising development for those patients who suffer from OA, since OA is often chronic and debilitating in nature. Additionally, treatment options are limited and medications tend to wane in efficacy over time. Some patients with longstanding OA exhaust all viable treatment options after many years of treatment. It is too early to know what effect this investigational new drug will have on the treatment of OA globally, but this is certainly one to watch and we’ll keep you posted on future developments.

Should the drug prove to be efficacious in the treatment of OA, it will raise many potential issues for the MSA process. As OA occurs as a natural part of the aging process or also as a sequela of traumatic injury, the drug has a potential to be prescribed for an industrial condition and included in an MSA allocation. One question presented is the potential impact on all other treatment modalities currently prescribed for OA. Current treatment for OA includes prescription NSAIDs, physical therapy, acupuncture, bracing, narcotics, viscosupplementation or cortisone injections, arthroscopy and arthroplasty for treatment of end-stage disease.  Will GLPG1972/S201086 have the potential to decrease or eliminate the need for some or all the common OA treatments which are currently prescribed and routinely included in MSA allocations? Will GLPG1972/S201086 merely postpone the need for arthroplasty or will it eliminate the need for surgery in some individuals? If GLPG1972/S201086 merely postpones the need for surgery, will CMS require the inclusion of the medication over the Claimant’s life expectancy even though arthroplasty is also included in the MSA? As the cost of GLPG1972/S201086, if and when it is FDA- approved, can reasonably be anticipated to be higher than the cost of the routine treatments now prescribed, will CMS expect inclusion of all routine treatments in addition to the medication and ultimate surgery, thereby possibly increasing the cost of future medical treatment exponentially?   Whether the drug will be used as monotherapy or in combination with other drugs will likely be borne out by additional clinical trials that we will continue to follow. The effect the drug has on clinical endpoints such as surgery will also likely be studied as part of the cost vs benefit analysis. The promise presented by GLPG1972/S201086 is one that could favorably impact quality of life for individuals diagnosed with OA, while presenting a corresponding significant impact on the cost of future medical care in the setting of an industrial injury.