Product Name:
{drug name}
Product Type:
Registered
Intended Use:
Promotional Material
Assessment Type:
Regulatory Review
Subjective Language Analysis
{drug name} has a long history of treating patients
The statement "{drug name} has a long history of treating patients" might benefit from more specific context. Consider providing concrete data or timeframes to support claims about {drug name}'s longevity or widespread use.
stable presence globally for 28 years
When discussing {drug name}'s "stable presence globally for 28 years", it may be helpful to provide more specific information about its availability or adoption in different regions. This could offer clearer context for readers.
over one million patients having received treatment
While mentioning "over one million patients having received treatment" can be informative, it might be beneficial to provide additional context about treatment outcomes or satisfaction rates to give a more comprehensive picture of {drug name}'s impact.
Claim Validation
{drug name} has a long history of treating patients with joint and skin conditions all over the world
{drug name} is indicated for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in patients with moderately to severely active rheumatoid arthritis (RA).
{drug name} has had a stable presence globally for 28 years, with over one million patients having received treatment
This claim about {drug name}'s global presence and patient numbers is not likely to be found on an FDA claims sheet. The FDA focuses on safety and efficacy information, not market presence or patient numbers.
{drug name} is used to treat a range of joint and skin conditions
{drug name} is a tumor necrosis factor (TNF) blocker indicated for the treatment of: Rheumatoid Arthritis (RA) (1.1) Polyarticular Juvenile Idiopathic Arthritis (JIA) in patients aged 2 years or older (1.2) Psoriatic Arthritis (PsA) (1.3) Ankylosing Spondylitis (AS) (1.4) Plaque Psoriasis (PsO) (1.5)
{drug name} is approved for the treatment of Rheumatoid arthritis
{drug name} is a tumor necrosis factor (TNF) blocker indicated for the treatment of: Rheumatoid Arthritis (RA) (1.1)
{drug name} is approved for the treatment of Ankylosing spondylitis
{drug name} is a tumor necrosis factor (TNF) blocker indicated for the treatment of: Ankylosing Spondylitis (AS) (1.4)
{drug name} is approved for the treatment of Non-radiographic axial spondyloarthritis
The FDA text does not mention non-radiographic axial spondyloarthritis
{drug name} is approved for the treatment of Psoriatic arthritis
{drug name} is a tumor necrosis factor (TNF) blocker indicated for the treatment of: Psoriatic Arthritis (PsA) (1.3)
{drug name} is approved for the treatment of Juvenile idiopathic arthritis
{drug name} is a tumor necrosis factor (TNF) blocker indicated for the treatment of: Polyarticular Juvenile Idiopathic Arthritis (JIA) in patients aged 2 years or older (1.2)
{drug name} is approved for the treatment of Plaque psoriasis
{drug name} is a tumor necrosis factor (TNF) blocker indicated for the treatment of: Plaque Psoriasis (PsO) (1.5)
{drug name} is approved for the treatment of Pediatric psoriasis
{drug name} is indicated for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis (JIA) in patients ages 2 and older.
Benefits vs. Risks Presentation
Benefits
Information: {drug name} has a long history of treating patients with joint and skin conditions all over the world. {drug name} has had a stable presence globally for 28 years, with over one million patients having received treatment. {drug name} is used to treat a range of joint and skin conditions including: Rheumatoid arthritis, Ankylosing spondylitis, Non-radiographic axial spondyloarthritis, Psoriatic arthritis, Juvenile idiopathic arthritis, Plaque psoriasis, Paediatric psoriasis.
Presentation: Prominently presented in large, bold font
Risk Information
Information: This booklet does not replace the advice of your healthcare provider. Please speak to your doctor if you have any concerns about your condition or treatment.
Presentation: Small font, placed at the top of the flyer
Analysis
Risk Information Presentation
Risk Level: Important
It may be beneficial to review the presentation of risk information for {drug name}. Consider whether more specific details about potential side effects or risks could be included to provide a comprehensive overview for patients.
Balance of Information
Risk Level: Important
The balance between benefit and risk information for {drug name} could be reviewed. Consider whether adjusting the emphasis on each could provide a more balanced presentation of the product.
Clarity of Risk Information
Risk Level: Moderate
The presentation of risk information for {drug name} might benefit from more specific details. Consider whether providing more concrete information about potential risks or side effects could enhance patient understanding.
Overall Analysis
This material about {drug name} may benefit from a review of its information presentation. Consider evaluating the balance between benefit and risk information, and whether more specific details about potential risks could be included. These adjustments could potentially enhance the material's alignment with fair balance requirements and support informed decision-making for patients considering {drug name} treatment.