In drug news, a generic 2% diclofenac sodium solution is now available, denosumab is promising to treat osteoporosis, and the FDA has approved sarilumab to treat adults with RA…
EMA Panel Recommends Nod for Sanofi, Regeneron’s Arthritis Drug
(Reuters)—A European Medicines Agency panel said on Friday it recommended granting marketing approval to Sanofi and Regeneron’s experimental drug to treat rheumatoid arthritis (RA). The Committee for Medicinal Products for Human Use gave a positive opinion on the drug, sarilumab (Kevzara), citing its ability to reduce the signs and symptoms of RA. Sarilumab, the active…
Sarilumab Approval Stalled; Piclidenoson Promising for Psoriasis
Due to manufacturing deficiencies found during a routine inspection by the FDA, approval of sarilumab for treating RA has slowed until facility issues are resolved…
Rheumatology Drug Updates: Biosimilars Seek Regulatory Approval in the U.S., Europe; Methotrexate Underused
Biosimilars Receive Positive News On Nov. 19, 2015, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended granting marketing authorization for SB4, an etanercept biosimilar product that will be called Benepali.1 If approved, Benepali can be used to treat rheumatoid arthritis (RA), psoriatic arthritis (PsA), axial spondyloarthritis and plaque psoriasis….
Sarilumab Is Effective for RA, Pregabalin Fails to Meet Study Endpoint & Ibuprofen Can Be Administered with a Patch
Sarilumab is proving effective for treating RA. In a clinical trial, pregabalin did not meet its endpoint for treating post-traumatic peripheral neuropathic pain. And a 12-hour ibuprofen patch is in development…
EULAR 2014: Non-Tumor Necrosis Factor Biologics Update
Clinical trials on rheumatology drugs, including sarilumab, show promise for patients with rheumatoid arthritis also taking methotrexate