FDA News & Updates
New Treatments Approved for Patients with Giant-Cell Arteritis and Moderate-to- Severe Rheumatoid Arthritis
Tocilizumab is the first therapy approved by the FDA for the treatment of adult patients with this type of vasculitis, and was granted Breakthrough Therapy designation and Priority Review for this indication.
Dr Gottlieb is a physician, medical policy expert, and public health advocate who previously served as the FDA’s Deputy Commissioner for Medical and Scientific Affairs, and as Senior Advisor to the FDA Commissioner.
- Adalimumab Biosimilar Approved to Treat Multiple Indications
- First Drug for Duchenne Muscular Dystrophy Granted Accelerated Approval
- FDA Approves Etanercept Biosimilar for Multiple Indications
The US Food and Drug Administration (FDA) has approved etanercept-szzs, a biosimilar to etanercept (Enbrel), for the treatment of multiple inflammatory diseases, according to an announcement by the organization. The biosimilar injection has been approved to treat patients with moderate-to-severe rheumatoid arthritis; moderate-to-severe polyarticular juvenile idiopathic arthritis; active psoriatic arthritis; active ankylosing spondylitis; and chronic, moderate-to-severe plaque psoriasis.
On May 27, 2016, the FDA approved fluciclovine F18 (Axumin; Blue Earth Diagnostics) injection, a radioactive diagnostic imaging agent used to detect recurrent prostate cancer.
On May 18, 2016, the FDA granted accelerated approval to atezolizumab (Tecentriq; Genentech) for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or after platinum-containing chemotherapy, or for those who have had disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.
Immediate-release opioid analgesics will now require boxed warnings regarding the serious risks for abuse, addiction, overdose, neonatal opioid withdrawal syndrome (NOWS), and death associated with the drugs, according to an announcement by the US Food and Drug Administration (FDA). This is the latest in a number of steps recently outlined by the FDA in their bid to reassess their approach to opioid medications.
Ixekizumab (Taltz) has been approved by the US Food and Drug Administration (FDA) for use in patients with moderate-to-severe plaque psoriasis, the agency has announced. Administered as an injection, ixekizumab is an antibody that binds and inhibits the inflammatory response of the inflammation-causing interleukin-17A protein.
The US Food and Drug Administration (FDA) announced the approval of Inflectra (infliximab-dyyb)—a biosimilar to Remicade (infliximab)—for patients with chronic severe plaque psoriasis, and active ankylosing spondylitis or psoriatic arthritis. The biosimilar is also indicated for adult patients with moderately to severely active ulcerative colitis who have inadequately responded to standard therapy; in combination with methotrexate for patients with moderately to severely active rheumatoid arthritis; and patients aged ≥6 years with moderately to severely active Crohn’s disease who have had an inadequate response to conventional therapy. Inflectra is the second biosimilar approved by the FDA.
The U.S. Food and Drug Administration today approved Alecensa (alectinib) to treat people with advanced (metastatic) ALK-positive non-small cell lung cancer (NSCLC) whose disease has worsened after, or who could not tolerate treatment with, another therapy called Xalkori (crizotinib).
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