New Approvals
Earlier this year, the European Commission approved abatacept (Orencia) in combination with methotrexate (MTX) for treating moderate to severe active polyarticular juvenile idiopathic arthritis in children six years of age and older who have had an insufficient response to other disease-modifying antirheumatic drugs (DMARDs), including at least one tumor necrosis factor (TNF) α inhibitor.1 To date, there are limited DMARD options for treating children. This approval of abatacept is based on the results of the Abatacept Withdrawal study to Assess efficacy and safety in Key Endpoints in juvenile idiopathic arthritis Not responding to current treatment (the AWAKEN study). This study evaluated the safety and efficacy of abatacept in patients six to 18 years of age. Following an initial open-label lead-in period, the overall adverse event frequency was 70%, and infections occurred at a frequency of 36%. Only patients that obtained an ACR Pediatric 30 response were randomized in the second phase, to receive either abatacept or placebo. In the double-blinded second phase, there were significantly fewer disease flares in abatacept-treated patients compared with placebo-treated patients (20% versus 53%). Adverse events in the second phase did not differ significantly between treatment groups. Acute infusion reactions occurred in 2–4% of patients. No opportunistic infections were identified. In another study, abatacept improved quality of life for children, allowing them to miss fewer school days.
Oral transmucosal fentanyl citrate lozenges have been approved by the U.S. Food and Drug Administration (FDA). It is the generic of Actiq and is available in six different doses.2
Hydromorphone extended-release tablets (Exalgo) have been approved by the FDA for treating moderate to severe pain in patients that require treatment for an unlimited period of time.3
Pipeline
The FDA is expected to review the complete response submission related to denosumab (Prolia) for the treatment of postmenopausal osteoporosis by July 25, 2010.4 Information submitted included more information on postmarketing surveillance and updated safety data. Denosumab, if approved, will be administered every six months as a subcutaneous injection. It is also being investigated for the treatment of rheumatoid arthritis (RA) and to delay bone metastases and treat bone destruction in patients with advanced cancer.
Hydrocodone controlled-release without acetaminophen (ZX002) has begun phase 3 clinical trials to treat moderate to severe pain in patients requiring around-the-clock opioids.5 There are currently no hydrocodone “monotherapies” available, nor are there any controlled-release hydrocodone products, even though hydrocodone is one of the most widely prescribed opioids in combination with acetaminophen. ZX002 is a novel, oral, controlled-release formulation using Elan’s Spheroidal Oral Drug Absorption System (SODAS).