Recordati Expands ISTURISA® Indication for Cushing’s Syndrome
Recordati Announces Expanded Approval of ISTURISA®
Recordati has made significant progress in the treatment of Cushing’s syndrome with the approval of ISTURISA® (osilodrostat) by the U.S. FDA. This expansion allows for the treatment of endogenous hypercortisolemia in adults who have not benefited from surgery or for whom surgery is not an option. This approval is expected to provide a new therapeutic avenue for patients suffering from this rare endocrine disorder.
Understanding Cushing’s Syndrome and ISTURISA®
Cushing's syndrome, characterized by excessively high cortisol levels, can profoundly affect patients and their families. ISTURISA® acts as a cortisol synthesis inhibitor, specifically targeting the enzyme 11?-hydroxylase, thus normalizing the heightened cortisol levels associated with the condition. This expanded indication not only offers hope to those affected but is also backed by an extensive clinical development program involving over 350 patients.
Impact of Cushing’s Syndrome on Patients
Cushing's syndrome can lead to severe complications such as diabetes, osteoporosis, cardiovascular diseases, and increased susceptibility to infections if left untreated. The medication ISTURISA® plays a crucial role in mitigating these effects, ensuring that patients can regain control over their health.
Scott Pescatore, Executive Vice President of Rare Diseases at Recordati, expressed his enthusiasm regarding this approval, emphasizing that the expanded label for ISTURISA® represents a critical advance in treating an unmet medical need. Elevated cortisol levels, if uncontrolled, pose significant health risks, and this approval will allow more patients to access effective treatment.
Clinical Significance of ISTURISA®
ISTURISA® offers a much-needed option for adult patients with endogenous hypercortisolemia and expands on the previous treatments limited to specific cases. This approval signifies a critical shift in the management of Cushing's syndrome, paving the way for enhanced treatment strategies.
Expert Opinions on Osilodrostat Expansion
Healthcare professionals, such as Dr. Maria Fleseriu, have noted that the expansion of the ISTURISA® indication is a pivotal development. It facilitates normalization of cortisol levels in patients unable to undergo surgery, thereby improving patient outcomes and quality of life.
Safety Information Regarding ISTURISA®
As with any medication, ISTURISA® comes with important safety information. It is crucial for patients to discuss their medical history with healthcare providers before starting treatment, especially concerning heart issues, electrolyte levels, and pregnancy status. Monitoring will be essential to mitigate potential side effects associated with treatment.
Common side effects may include low cortisol levels, fatigue, nausea, and swelling. It is vital for patients to report any adverse effects to their healthcare providers promptly, ensuring ongoing safety and efficacy of the treatment regimen.
About Recordati and ISTURISA®
Recordati is an esteemed international pharmaceutical group with a long-standing commitment to addressing health care challenges through innovative products. Their role in the treatment of rare diseases and specialty care is significant, with operations across numerous countries and a workforce dedicated to improving patient care.
ISTURISA® is already recognized in various international markets, securing its place as a valuable therapeutic option beyond U.S. borders. With commitments to continuous development and innovation, Recordati maintains its strategic focus on expanding access to vital medications for patients worldwide.
Frequently Asked Questions
What is ISTURISA® used for?
ISTURISA® is a prescription drug used to treat elevated cortisol levels in adults with Cushing’s syndrome who cannot have surgery or have not had success with surgical interventions.
How does ISTURISA® work?
ISTURISA® works by inhibiting the enzyme 11?-hydroxylase, which plays a crucial role in cortisol synthesis, thereby helping normalize cortisol levels in patients.
What are the possible side effects of ISTURISA®?
Possible side effects include low cortisol levels, fatigue, nausea, and swelling. Patients are advised to report any severe symptoms to their healthcare provider.
Is ISTURISA® safe for everyone?
ISTURISA® may not be safe for individuals with certain pre-existing conditions. Patients should consult their healthcare providers to assess individual risks before starting treatment.
Where is Recordati located?
Recordati is an international pharmaceutical group with its roots in Italy, operating in around 150 countries globally and focusing on specialty and rare diseases.
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