Recordati Rare Diseases, Inc., based in Lebanon, NJ, has recently acquired the rights to SIGNIFOR® LAR and the FDA approval for ISTURISA®(osilodrostat). Both products treat pituitary diseases. SIGNIFOR LAR, a “2nd generation” somatostatin analog given once every four weeks by injection, was approved by the FDA for Acromegaly in 2014, and Cushing’s disease in 2018. ISTURISA is an oral cortisol synthesis inhibitor for Cushing’s disease approved by the FDA on March 6th, 2020.
Although this shift of SIGNIFOR LAR to Recordati has taken place, SIGNIFOR LAR will continue to be available uninterrupted to patients and healthcare providers through ACCREDO specialty pharmacy.
Recordati has significantly enhanced both the physician and patient support services offered. Through Accredo, the company will be supporting benefits verifications, clinical nurse support for questions, and a mobile administration program. Recordati will offer a copay assistance program to help eligible patients with their insurance copayments or co-insurance, and a patient assistance program to help eligible uninsured or underinsured patients receive SIGNIFOR LAR. The company has created a website for more information about SIGNIFOR LAR at www.signiforlar.com.
Recordati will be bringing ISTURISA to patients through the specialty pharmacy channel to ensure a high level of support for patients and healthcare providers. The company will provide resources to ensure access to the medication and support patients through clinical nurse specialists, pharmacy engagement, and experts in insurance reimbursement issues.
The availability of ISTURISA is expected to be late in the 2nd quarter of 2020. The FDA approval of ISTURISA is based on data generated by the clinical program showing that ISTURISA leads to normalization of cortisol levels in the majority of patients, as well as improvement in multiple clinical features of the disease.
In a Phase 3 LINC‐3 study, a significantly higher proportion of patients treated with ISTURISA maintained normal mean urinary free cortisol (mUFC) at the end of the 8‐week randomized withdrawal period (week 34) versus placebo (86% vs. 29%).
To learn about ISTURISA and access a link to the prescribing information go to www.isturisa.com
About Recordati
Recordati Rare Diseases, Inc, is a biopharmaceutical company committed and entirely focused on providing therapies to the rare disease communities in the United States. The US company is a part of the rare disease business within the Recordati Group, a public international pharmaceutical company established in 1926 and based in Milan, Italy.
By the way, in Italian “recordati” means REMEMBER ME!
If you would like additional information about Recordati Rare Diseases, you can learn more here https://www.recordatirarediseases.com/us
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