FDA Approves Biosimilar for Humira
The FDA recently approved Abrilada (adalimumab-afzb) a biosimilar for Humira® (adalimumab), indicated for the treatment of:
- Rheumatoid arthritis
- Juvenile idiopathic arthritis
- Psoriatic arthritis
- Ankylosing spondylitis
- Adult Crohn’s Disease
- Ulcerative colitis
- Plaque psoriasis
In various industries, workers may develop osteoarthritis by experiencing cumulative or acute trauma, resulting in the prescription of osteoarthritis drugs. This has led to certain specialty medications for inflammatory conditions appearing in workers' comp claims, with drugs for other arthritis conditions being prescribed off-label. Furthermore, it is possible for occupational injury to aggravate pre-existing inflammatory joint disease that may have been previously mild.
For these reasons, specialty arthritis injections like Humira, and now Abrilada, may be seen in workers’ compensation claims. As specialty drugs often come with high costs, the presence of biosimilars can reduce those costs when utilized in appropriate populations, assuming the medication is prescribed for the appropriate indications.
FDA Approves RediTrex for Rheumatoid Arthritis
The FDA has also approved once-weekly RediTrex (methotrexate) subcutaneous injections for the management of severe active rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, and symptomatic control of disabling psoriasis.
Once more, arthritis drugs may be prescribed off-label in workers’ compensation for the treatment of occupational osteoarthritis resulting from cumulative or acute trauma, or when a pre-existing inflammatory joint disease is aggravated by occupational injury, meaning this drug could potentially appear in workers’ comp claims.
RediTrex is available in varying dosages, depending on which condition it is meant to treat. Common adverse reactions include nausea, abdominal pain, dyspepsia, mouth sores, rash, nasopharyngitis, diarrhea, vomiting, headache, dizziness, and more.
RediTrex is contraindicated with pregnancy, alcoholism or liver disease, preexisting blood dyscrasias, and more. For further information, read the FDA-approved label.
FDA Approves Xcopri for Partial-Onset Seizures
The FDA has also approved Xcopri (cenobamate tablets) for oral use in the treatment of partial-onset seizures.
Various seizure drugs are common in workers’ comp, as head injuries from falls and other traumas can lead to seizure disorders, including traumatic brain disorder (TBI). For this reason, it is possible the Xcopri could eventually make its way into workers’ comp claims.
According to the FDA-approved label, adverse reactions for Xcopri include somnolence, dizziness, fatigue, diplopia, and headache. Xcopri is pending controlled substance schedule, meaning the drug may require close monitoring. Xocpri will be available in various strengths, ranging from 12.5 mg to 200 mg.
FDA Fast Tracks a New PTSD Drug
In other news, the FDA has granted Fast Track designation to BNC210, a drug currently in development from Bionomics Limited, created for the treatment of post-traumatic stress disorder (PTSD) and other trauma-related and stressor-related disorders, including anxiety disorders, comorbid anxiety and depression.
As legislation across the country continues to expand workers’ comp coverage for PTSD to first responders, understanding the therapies available for PTSD, be they pharmacologic or not, is important to managing claims, and any new drugs for PTSD could make a serious impact in workers’ comp.
Bionomics Limited claims BNC210 does not cause sedation, memory or motor impairment, and is not addictive, unlike other antianxiety drugs, such as benzodiazepines.
A Phase 2, 12-week, double-blind, placebo-controlled study of 193 patients found that BNC210 did not significantly improve symptoms, but a dose-response relationship predicted to meet the primary endpoint was established based on this trial data.
These findings were enough to spur the FDA into granting BNC210 Fast Track designation, which increases communication between drug developers and the FDA. With Fast Track drugs, the FDA reviews portions of the New Drug Application (NDA) ahead of submission of the completed application, which can significantly help manufacturers in improving their NDAs, increasing their likelihood of approval.
