Celltrion Gains FDA Nod for New STEQEYMA® Pediatric Formulation
Celltrion Receives FDA Approval for Pediatric STEQEYMA®
Celltrion, a pioneering biopharmaceutical company, has made significant strides in enhancing treatment options for pediatric patients. The U.S. Food and Drug Administration (FDA) has approved a new presentation of STEQEYMA® (ustekinumab-stba), specifically targeting those under 60kg suffering from plaque psoriasis (PsO) or psoriatic arthritis (PsA). This approval introduces a 45mg/0.5mL solution in a single-dose vial for subcutaneous injection, thereby offering greater dosing flexibility for young patients.
Expanded Dosing Options Enhance Treatment Flexibility
The newly approved formulation allows healthcare providers the ability to adapt treatment plans according to individual patient needs. Previously, the STEQEYMA line included 45mg/0.5mL and 90mg/mL solutions in prefilled syringes and a 130mg/26mL option for intravenous infusion, but now extends to include presentations tailored for the pediatric population. This helps ensure continuity of care for younger patients facing the challenges of chronic inflammatory diseases.
Understanding the Significance of this Development
The introduction of this new dosage form of STEQEYMA aligns perfectly with the existing strengths and indications of its reference product, STELARA®. According to Vice President of Medical Affairs, Hetal Patel, PharmD MBA, managing inflammatory diseases in children often presents unique challenges. The availability of STEQEYMA in a new dosage form represents a significant advancement in fulfilling the specific needs of younger patients.
Commitment to Broadening Access for Patients
Thomas Nusbickel, Chief Commercial Officer at Celltrion USA, emphasized the company's dedication to ensuring all patient populations, including those aged 6 years and older with chronic inflammatory conditions, have access to appropriate treatments. The expanded indication of STEQEYMA reflects Celltrion's commitment to enhancing the quality of care for young individuals with difficult-to-manage conditions, reinforcing their legacy in immunology.
Thorough Research Underpins FDA Approval
The FDA's approval decision was rooted in a comprehensive review of clinical evidence, including results from a phase III study focused on adult patients with moderate to severe plaque psoriasis. This study explored the relative effectiveness between STEQEYMA and its reference product, ustekinumab. Findings revealed the two products are highly similar in safety and efficacy, solidifying the FDA's decision to grant full interchangeability with STELARA across all indications.
About STEQEYMA® and Its Indications
STEQEYMA® is not only pivotal for treating pediatric patients but also serves multiple indications across various age groups. Patients aged 6 years and older may receive STEQEYMA for treating plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis. This inclusive approach ensures that the drug can be utilized in treating significant autoimmune disorders in both adults and children alike.
Safety Information Regarding STEQEYMA®
As with any pharmaceutical product, safety is paramount when considering STEQEYMA. It's crucial to recognize the contraindications, such as hypersensitivity to ustekinumab or any component of the formulation. Patients must be assessed for tuberculosis before initiating treatment to mitigate serious infection risks, and regular monitoring for signs of malignancy during administration is advised. It's also essential to note that live vaccines should not be administered concurrently with STEQEYMA treatment.
Frequently Asked Questions
What is STEQEYMA® used for?
STEQEYMA® is indicated for treating plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis in both adults and pediatric patients aged 6 years and older.
Who has approved STEQEYMA®?
The U.S. Food and Drug Administration (FDA) has granted approval for the new presentation of STEQEYMA®.
How does this new formulation benefit pediatric patients?
This formulation provides flexibility in dosing for pediatric patients weighing under 60kg, enhancing treatment options for plaque psoriasis and psoriatic arthritis.
What are the common side effects of STEQEYMA®?
Common adverse reactions include nasopharyngitis, injection site reactions, and upper respiratory infections, among others. Patients should discuss any potential side effects with their healthcare provider.
Where can I find more information about STEQEYMA®?
For detailed prescribing information, consult your healthcare provider or refer to the official documentation provided by Celltrion.
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