US FDA Approves the Cyltezo® Pen, a New Autoinjector Option
Boehringer Ingelheim announced today that the U.S. Food and Drug Administration (FDA) has approved the Cyltezo® Pen, a new autoinjector option for Cyltezo (adalimumab-adbm), an FDA-approved Interchangeable biosimilar to Humira® (adalimumab). Initially approved as a pre-filled syringe, Cyltezo is indicated to treat multiple chronic inflammatory diseases. The 40 mg/0.8 mL pre-filled Cyltezo Pen will be available in two-, four- and six-pack options on July 1, 2023.
The patient-centered design of the pen features a one-button, three-step activation, with 100% drug visibility and a protected needle.
INDICATIONS FOR CYLTEZO®(adalimumab-adbm) injection, for subcutaneous use
Rheumatoid Arthritis: Cyltezo is indicated for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis. Cyltezo can be used alone or in combination with methotrexate or other non-biologic disease-modifying anti-rheumatic drugs (DMARDs).
Juvenile Idiopathic Arthritis: Cyltezo is indicated for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. Cyltezo can be used alone or in combination with methotrexate.
Psoriatic Arthritis: Cyltezo is indicated for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. Cyltezo can be used alone or in combination with non-biologic DMARDs.
Ankylosing Spondylitis: Cyltezo is indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis.
Crohn’s Disease: Cyltezo is indicated for the treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older.
Ulcerative Colitis: Cyltezo is indicated for the treatment of moderately to severely active ulcerative colitis in adult patients.
