Approval Journey of Oczyesa in Treating Acromegaly Unfolds
Camurus Receives Positive CHMP Opinion for Oczyesa
Today, Camurus announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended market authorization for Oczyesa, a long-acting subcutaneous depot formulation of octreotide.
Oczyesa is intended for maintenance treatment in adults with acromegaly who respond to somatostatin analogues. Fredrik Tiberg, the President & CEO of Camurus, expressed satisfaction with the CHMP’s positive recommendation, highlighting the drug’s ability to improve the standard of care. By enhancing octreotide plasma exposure and simplifying the administration process through a convenient autoinjector pen, Oczyesa aims to empower patients in managing their condition.
Significant Clinical Evidence Supports Oczyesa
The CHMP's recommendation is supported by an extensive clinical program involving seven studies, including two notable Phase 3 trials. The ACROINNOVA 1 study indicated that Oczyesa significantly increases the likelihood of achieving normalized insulin growth factor-1 (IGF-1) levels compared to placebo.
In the subsequent ACROINNOVA 2 study, improvements in symptoms and quality of life were evident after 52 weeks of treatment. Patients reported better symptom management and treatment satisfaction compared to standard care. While some gastrointestinal and nervous disorders occurred, these were consistent with what is typically observed in similar treatments.
Expected Timeline for Commission Decision
A final decision on Oczyesa's marketing authorization from the European Commission is anticipated within the following months, reinforcing the importance of this medication for patients with acromegaly.
Understanding Acromegaly: A Complex Condition
Acromegaly is marked by excessive growth hormone production, usually due to a pituitary gland tumor, resulting in increased IGF-1 levels. This leads to abnormal growth patterns, affecting bones and tissues, and presents various symptoms including fatigue, joint pain, and visual field defects.
The prevalence of acromegaly is relatively low, with about 60 cases per million people, indicating the need for effective treatment options. If left untreated, acromegaly significantly impacts quality of life and increases mortality risk, underscoring the relevance of medicines like Oczyesa.
The Oczyesa Development Journey
CAM2029, known as Oczyesa, is under development for various indications including gastroenteropancreatic neuroendocrine tumors and polycystic liver disease. The CAM2029 clinical program incorporates multiple phases of trials, showcasing its potential efficacy.
This formulation offers a significant increase in bioavailability—about five times—compared to currently approved intramuscular octreotide preparations. In trials, CAM2029 demonstrated superior biochemical control over placebo, improving not just clinical outcomes but also patient satisfaction compared to traditional treatments.
User-Friendly Administration
Using Camurus' innovative FluidCrystal technology, the product is designed for straightforward self-administration through a pen system that conceals a small-gauge needle. It remains stable at room temperature, making it a practical choice for patients.
About Camurus: Focused on Patients
Camurus stands dedicated to developing innovative, long-acting therapies aimed at improving patient well-being. With a focus on severe chronic conditions, their portfolio includes drugs targeting pain management, cancer treatment, and endocrine disorders.
Headquartered in Lund, Sweden, Camurus operates extensively within Europe, the US, and Australia, emphasizing a commitment to scientific innovation and patient needs. Their stocks are publicly traded on Nasdaq Stockholm under the ticker CAMX.
Frequently Asked Questions
What is Oczyesa used for?
Oczyesa is used for the maintenance treatment of adults with acromegaly who have shown a positive response to somatostatin analogues.
What are the main clinical findings for Oczyesa?
Clinical trials demonstrated that Oczyesa significantly improved IGF-1 levels and overall patient quality of life, as well as reduced symptoms compared to standard treatments.
What technology is used in Oczyesa?
Oczyesa utilizes Camurus' proprietary FluidCrystal technology, which allows for convenient monthly self-administration.
How common is acromegaly?
Acromegaly is estimated to occur in about 60 individuals per million people, emphasizing the rarity yet significance of effective treatments.
Is Oczyesa safe for use?
The safety profile of Oczyesa has shown consistency with other treatments; any side effects experienced align with what's typically seen with hormone treatments.
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