Denosumab injection (Prolia) has been granted a priority review by the FDA for the treatment of bone metastases to reduce skeletal-related events in patients with cancer.9 Denosumab was studied in approximately 6,900 patients, including in head-to-head trials that compared it to zoledronic acid. This same indication has been submitted in Europe, Canada, and Australia.
DM-1796, extended-release once-daily gabapentin, has had its NDA filed with the FDA for the treatment of postherpetic neuralgia.10
Ibuprofen/famotidine (Duexa) has had its NDA filed with the FDA to reduce the risk of upper gastrointestinal (GI) ulcer development in patients with pain and arthritis.11 Phase 3 clinical trials enrolled more than 1,500 patients with mild to moderate pain.12 Patients that were treated with this combination had 50% fewer upper GI ulcers compared with patients that received ibuprofen monotherapy. The PDUFA date is anticipated to be in the first quarter of 2011.
Laquinimod is a new oral quinoline-3-carboxamide derivative that is currently in Phase 2 clinical trials to treat multiple sclerosis (MS).13 In addition to managing MS, this agent has shown preclinical therapeutic efficacy in models of other autoimmune diseases, including rheumatoid arthritis (RA), insulin-dependent diabetes mellitus, Guillain Barré Syndrome, lupus nephritis, and Crohn’s disease. Because of this, the manufacturer, Teva, has initiated clinical trials utilizing laquinimod in Crohn’s disease and lupus nephritis.14 Teva has begun recruitment of patients for a Phase 2 clinical trial of laquinimod in lupus patients with active lupus arthritis.15
Prednisone tablet low dose has been reformulated in a novel, modified-release preparation known as Lodotra and is currently in Phase 3 clinical trials as a circadian cytokine modulator for the treatment of RA.16 Compared with RA patients receiving placebo and ongoing disease-modifying antirheumatic drugs, Lodotra use showed a statistically significant improvement in ACR response criteria in a 12-week, double-blind trial known as CAPRA-2 (Circadian Administration of Prednisone in RA-2). A total of 350 patients were evaluated. ACR 20 and ACR 50 responses were statistically significantly better for Lodotra-treated patients compared with placebo-treated patients. The relative reduction in morning stiffness compared with baseline (134 minutes) was also statistically significantly better for active-treated versus placebo-treated patients.
Rilonacept (Arcalyst), currently in Phase 3 clinical trials to treat gout, has met its primary endpoint of decreasing the number of gout flares compared with placebo.17 Studies are still ongoing, and the manufacturer plans to file an NDA by mid-2011.
Generic rituximab is being investigated by Teva Pharmaceutical Industries, the world’s largest generic company, as a biosimilar of Rituxan/MabThera.18 A European trial is now recruiting patients with RA to compare branded rituximab to the generic copy, which is known as TL011. It is anticipated that this study, which plans to include 60 patients, will be concluded in August 2011, with a potential launch time in the second half of 2014. Teva formed a biosimilars partnership with the Swiss manufacturer Lonza to research and bring biologic generics (e.g., biosimilars, follow-on generics) to the market.